| Abacavir Sulfate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Abacavir Sulfate/Dolutegravir Sodium/Lamivudine |
Tablet |
II (Paddle) |
85 |
0.01 M Phosphate Buffer with 0.5% sodium dodecyl sulfate (SDS), pH 6.8 |
900 |
Abacavir and lamivudine: 10, 15, 20, 30 and 45; Dolutegravir: 5,15, 25, 35 and 45. |
2015/05/28 |
| Abacavir Sulfate/Dolutegravir Sodium/Lamivudine |
Tablet (For Suspension) |
II (Paddle) |
50 |
0.01 M Phosphate Buffer with 0.5 mM EDTA, pH 6.8 |
500 |
5, 10, 15, 30, 45 and 60 |
2023/10/06 |
| Abacavir Sulfate/Lamivudine |
Tablet |
II (Paddle) |
75 |
0.1 N HCl |
900 |
10, 20, 30, and 45 |
2007/01/03 |
| Abacavir Sulfate/Lamivudine/Zidovudine |
Tablet |
II (Paddle) |
75 |
0.1 N HCl |
Acid Stage: 900 mL; Buffer Stage: 1000 mL |
5, 10, 15, 30 and 45 |
2007/01/03 |
| Abemaciclib |
Tablet |
II (Paddle) |
75 |
0.01 N HCl |
900 |
5, 10, 15, 20 and 30 |
2017/11/16 |
| Abiraterone Acetate |
Tablet |
II (Paddle) |
50 |
0.25% SLS in 56.5 mM phosphate buffer, pH 4.5 |
900 |
10, 20, 30, 45 and 60 |
2013/02/28 |
| Abrocitinib |
Tablet |
II (Paddle) with peak vessels |
55 |
Citrate-phosphate buffer, pH 3.5 |
900 |
10, 20, 30 and 45 |
2023/05/18 |
| Acalabrutinib |
Capsule |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 15, 20 and 30 |
2023/08/17 |
| Acalabrutinib Maleate |
Tablet |
II (Paddle) |
75 |
5 Mm Phosphate buffer, pH 6.8 |
900 |
5, 10, 15, 20, 30, 45 and 60 |
2024/11/01 |
| Acamprosate Calcium |
Tablet (Delayed Release) |
I (Basket) |
180 |
Acid Stage: 0.1 N HCl
Buffer Stage: "Citrate-sodium hydroxide" buffer pH 6.8 (150 ml of 2N NaOH, 21.014 gm of citric acid and ultra-pure water to 1000 ml) (Method B) |
Media 1: 750 mL pH 1.1±0.1; Media 2: 950 mL pH 6.0±0.1; Media 3: 1000 mL pH 7.5±0.1 |
120 (Acid)
30, 60, 90, 120, and 180
(buffer) |
2005/12/20 |
| Acarbose |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Acarbose |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Acetaminophen |
Tablet (Extended Release) |
|
|
Refer to USP |
|
|
2011/03/03 |
| Acetaminophen |
Suppository |
II (Paddle) |
50 |
Phosphate buffer, pH 5 |
900 |
15, 30, 45, 60 and 90 |
2006/08/17 |
| Acetaminophen/Aspirin/Caffeine |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Acetaminophen/Butalbital |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Acetaminophen/Butalbital/Caffeine |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Acetaminophen/Butalbital/Caffeine/Codeine Phosphate |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Acetaminophen/Caffeine/Dihydrocodeine Bitartrate |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Acetaminophen/Caffeine/Dihydrocodeine Bitartrate |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Acetaminophen/Hydrocodone Bitartrate |
Tablet |
|
|
Refer to USP (provide individual unit data). |
|
|
2013/08/15 |
| Acetaminophen/Ibuprofen |
Tablet |
II (Paddle) |
50 |
50 mM Phosphate Buffer, pH 7.2 |
900 |
5, 10, 15, 20, and 30 |
2023/02/09 |
| Acetaminophen/Oxycodone |
Tablet |
|
|
Refer to USP |
|
|
2008/01/14 |
| Acetaminophen/Oxycodone HCl |
Tablet (Extended Release) |
II (Paddle) with sinker |
100 |
0.1 N HCl |
900 |
0.25, 0.5, 1, 2, 4, 6 and 8 hours |
2015/11/19 |
| Acetaminophen/Pentazocine HCl |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Acetaminophen/Tramadol HCl |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20 and 30 |
2006/03/04 |
| Acetaminophen; Butalbital |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/02/05 |
| Acetazolamide |
Capsule (Extended Release) |
II (Paddle) |
75 |
Acetate Buffer, pH 4.5 with 2.2% Tween 20 |
900 |
1, 2, 5, 7, 9, 12 and 14 hours |
2010/01/15 |
| Acetazolomide |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Acetylcysteine |
Tablet (Effervescent) |
|
|
Develop a dissolution method |
|
|
2016/07/28 |
| Acitretin |
Capsule |
|
|
Refer to USP |
|
|
2011/09/22 |
| Acrivastine/Pseudoephedrine HCl |
Capsule |
II (Paddle) |
50 |
0.01 N HCl |
900 |
5, 10, 15 and 30 |
2004/01/12 |
| Acyclovir |
Suspension |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 20, 30, 45 and 60 |
2004/02/20 |
| Acyclovir |
Tablet |
|
|
Refer to USP |
|
|
2007/06/18 |
| Acyclovir |
Capsule |
|
|
Refer to USP |
|
|
2012/01/05 |
| Acyclovir |
Tablet (Buccal) |
I (Basket) |
60 |
Phosphate Buffer, pH 6.0 |
1000 |
1, 2, 3, 5, 7, 9 and 12 hours |
2015/08/27 |
| Adagrasib |
Tablet |
II (Paddle) |
75 |
pH 6.8 phosphate buffer with 0.3% SLS |
900 |
10, 15, 30, 45 and 60 |
2024/02/05 |
| Adefovir Dipivoxil |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Afamelanotide |
Implant |
|
|
Develop a method to characterize in vitro release |
|
|
2023/05/18 |
| Afatinib Dimaleate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Albendazole |
Tablet |
|
|
Refer to USP |
|
|
2013/08/15 |
| Albendazole |
Tablet (Chewable) |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 15, 20, 30 and 45 |
2016/03/17 |
| Albuterol Sulfate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Albuterol Sulfate |
Tablet (Extended Release) |
II (Paddle) |
50 |
0.1 N HCl |
900 |
1, 2, 4, 6, 9 and 12 hours |
2007/04/09 |
| Alectinib HCl |
Capsule |
II (Paddle) with sinker |
100 |
pH 1.2, Simulated Gastric Fluid without pepsin, containing 4 % Triton X-100 [polyoxyethylene[10]octylphenyl ether] |
900 |
10, 20, 30, 45, 60, 75 and 90 |
2016/03/17 |
| Alendronate Sodium |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Alendronate Sodium/Cholecalciferol |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Alfuzosin HCl |
Tablet (Extended Release) |
II (Paddle) |
100 |
0.01 N HCl |
900 |
1, 2, 12, 20 hours |
2007/06/18 |
| Aliskiren Hemifumarate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Aliskiren Hemifumarate |
Capsule (pellet) |
I (Basket) |
100 |
0.01 M HCl (degas) |
500 |
5, 10, 15, 20, 30 and 45 |
2018/02/08 |
| Aliskiren Hemifumarate/Amlodipine Besylate |
Tablet |
I (Basket) |
100 |
0.01 N HCl, pH 2.0 |
500 |
10, 15, 20, 30 and 45 |
2012/06/07 |
| Aliskiren Hemifumarate/Amlodipine Besylate/Hydrochlorothiazide |
Tablet |
I (Basket) |
100 |
0.01 N HCl |
900 |
10, 15, 20, 30 and 45 |
2012/06/07 |
| Aliskiren Hemifumarate/Hydrochlorothiazide |
Tablet |
I (Basket) |
100 |
0.1 N HCl |
900 |
10, 15, 20, 30 and 45 |
2009/10/08 |
| Aliskiren Hemifumarate/Valsartan |
Tablet |
I (Basket) |
100 |
Phosphate Buffer, pH 6.8 |
1000 |
5, 10, 15, 20, 30 and 45 |
2010/12/23 |
| Allopurinol |
Suspension |
II (Paddle) |
75 |
0.01 N HCl |
900 |
10, 20, 30, 40, 50 and 60 |
2024/11/01 |
| Allopurinol |
Tablet |
|
|
Refer to USP |
|
|
2007/07/25 |
| Almotriptan Malate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Alogliptin Benzoate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Alogliptin Benzoate/ Metformin HCl |
Tablet |
II (Paddle) |
50 |
0.01 N HCl |
900 |
5, 10, 15, 20 and 30 |
2015/11/19 |
| Alosetron HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Alprazolam |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Alprazolam |
Tablet (Orally Disintegrating) |
II (Paddle) |
50 |
70 mM Potassium Phosphate Buffer, pH 6.0 |
500 |
2, 5, 10, 15 and 20 |
2008/10/06 |
| Alprazolam |
Tablet (Extended Release) |
I (Basket) |
100 |
1% Phosphate Buffer, pH 6.0 |
500 |
1, 4, 8, 12 and 16 hours |
2007/02/08 |
| Altretamine |
Capsule |
|
|
Refer to USP |
|
|
2010/01/29 |
| Aluminum Hydroxide/Magnesium Trisilicate |
Tablet (Chewable) |
|
|
Develop a dissolution method |
|
|
2022/05/12 |
| Alvimopan |
Capsule |
II (Paddle |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20, 30 and 45 |
2010/10/21 |
| Amantadine HCl |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Amantadine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Ambrisentan |
Tablet |
II (Paddle) |
75 |
0.05 M Acetate Buffer, pH 5.0 |
900 |
5, 10, 15, 30, and 45 |
2009/05/20 |
| Amifampridine |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2021/08/19 |
| Amifampridine Phosphate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2021/08/19 |
| Amiloride HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Amiloride HCl/Hydrochlorothiazide |
Tablet |
|
|
Refer to USP |
|
|
2012/06/07 |
| Aminocaproic Acid |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2024/01/03 |
| Aminosalicylic |
Granule (Delayed Release) |
II (Paddle) |
100 |
Acid Stage: 0.1 N HCl; Buffer Stage 2: pH 7.5 Phosphate Buffer |
1000 |
Acid Stage: 2 hours; Buffer Stage: 1, 2, 3 and 4 hours |
2008/07/14 |
| Amiodarone HCl (Test 1) |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Amiodarone HCl (Test 2) |
Tablet |
I (Basket) |
50 |
Acetate Buffer, pH 4.0, with 1% Tween 80 |
900 |
10, 20, 30, 45, 60 and 90 |
2004/01/12 |
| Amitriptyline HCl |
Tablet |
|
|
Refer to USP |
|
|
2008/01/14 |
| Amlodipine Besylate |
Tablet (Orally Disintegrating) |
II (Paddle) |
50 |
0.01 N HCl |
500 |
5, 10, 15 and 20 |
2008/10/06 |
| Amlodipine Besylate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Amlodipine Besylate/Atorvastatin Calcium |
Tablet |
II (Paddle) |
75 |
Phosphate Buffer, pH 6.8 |
900 |
5, 10, 15 and 30 |
2009/04/02 |
| Amlodipine Besylate/Benazepril HCl |
Capsule |
I (Basket) |
100 |
0.01 N HCl |
500 |
10, 20 , 30, 45, and 60 |
2007/06/20 |
| Amlodipine Besylate/Hydrochlorothiazide/Olmesartan Medoxomil |
Tablet |
II (Paddle) |
50 |
Phosphate Buffer, pH 6.8 |
900 |
5, 10, 15, 20, 30 and 45 |
2011/07/21 |
| Amlodipine Besylate/Hydrochlorothiazide/Valsartan |
Tablet |
|
|
Refer to USP |
|
|
2016/07/28 |
| Amlodipine Besylate/Olmesartan Medoxomil |
Tablet |
II (Paddle) |
50 |
Phosphate Buffer, pH 6.8 |
900 |
10, 20, 30 and 45 |
2008/08/11 |
| Amlodipine besylate/Perindopril Arginine |
Tablet |
II (Teflon coated paddle) |
75 |
0.01 N HCL |
1000 |
5, 10, 15, 20 and 30 |
2016/03/17 |
| Amlodipine Besylate/Telmisartan |
Tablet |
II (Paddle) |
75 |
Telmisartan: Phosphate Buffer, pH 7.5; Amlodipine: 0.01N HCl, pH 2 |
Telmisartan: 900; Amlodipine: 500 |
Telmisartan: 10, 15, 20, 30 and 45; Amlodipine: 10, 15, 20, 30 and 45 |
2010/08/05 |
| Amlodipine Besylate/Valsartan |
Tablet |
|
|
Refer to USP |
|
|
2016/07/28 |
| Amoxicillin |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Amoxicillin |
Tablet (Extended Release) |
II (Paddle) |
100 |
3 Stage dissolution: 50 mM potassium phosphate monobasic buffer at pH 4.0 (0-2 hours), 6.0 (2-4 hours) and 6.8 ( 4 hours and beyond) |
900 |
0.25, 0.5, 1, 2, 2.25, 2.5, 3, 4, 4.25, 4.5, 5 and 6 hours |
2010/10/21 |
| Amoxicillin |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Amoxicillin |
For Oral Suspension |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Amoxicillin/Clarithromycin/Lansoprazole |
Capsule/Tablet/Capsule (Copackage) |
|
|
Develop a dissolution method for Amoxicillin Capsules, Refer to USP for monographs of Clarithromycin Tablets and Lansoprazole Delayed-Release Capsules |
|
|
2024/01/03 |
| Amoxicillin/Clarithromycin/Omeprazole |
Capsule/Tablet/Capsule (Copackage) |
|
|
Develop a dissolution method for Amoxicillin Capsules, Refer to USP for monographs of Clarithromycin Tablets and Omeprazole Delayed-Release Capsules |
|
|
2024/01/03 |
| Amoxicillin/Clavulanate Potassium |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Amoxicillin/Clavulanate Potassium |
Tablet (Chewable) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Amoxicillin/Clavulanate Potassium |
Suspension |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Amoxicillin/Omeprazole Mg./Rifabutin |
Capsule (Delayed Release) |
I (Basket |
100 |
Amoxicillin/Rifabutin: 0.01 N HCl; Omeprazole: 0.1N HCl; Buffer Stage: 0.05M Phosphate buffer, pH 6.8 |
Amoxicillin/Rifabutin:900; Omeprazole: Acid Stage: 900; Buffer Stage:900; |
Amoxicillin/Rifabutin: 5, 10, 15, 20 and 30; Omeprazole: Acid Stage: 120; Buffer Stage: 5, 10, 15, 20 and 30; |
2020/08/27 |
| Amoxicillin; Clarithromycin; Vonoprazan Fumarate |
Capsule, Tablet, Tablet |
Clarithromycin and Vonoprazan: II (Paddle) |
Clarithromycin and Vonoprazan: 50 |
Amoxicillin: Develop a dissolution method; Clarithromycin: 0.1M Sodium Acetate Buffer (pH 5.0); Vonoprazan: 0.05M Acetate Buffer (pH 4.5) |
900 |
10, 15, 30, 45, 60 and 90 |
2024/02/05 |
| Amoxicillin; Vonoprazan Fumarate |
Capsule, Tablet |
Vonoprazan: II (Paddle) |
Vonoprazan: 50 |
Amoxicillin: Develop a dissolution method; Vonoprazan: 0.05M Acetate Buffer (pH 4.5) |
900 |
10, 15, 30, 45, 60 and 90 |
2024/02/05 |
| Amphetamine |
Tablet (Extended Release, Orally Disintegrating) |
II (Paddle |
75 |
Acid Stage: 0.1 N HCl; Buffer Stage: Phosphate Buffer, pH 6.8 |
Acid Stage: 900 mL; Buffer Stage: 1000 mL |
Acid Stage: 10, 15, 30, 45, 60, 90, 120; Buffer Stage: 5, 10, 15, 30 and 45 |
2016/07/28 |
| Amphetamine |
Suspension (Extended Release) |
|
|
Develop a dissolution method |
|
|
2016/12/22 |
| Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate |
Capsule (Extended Release) |
II (Paddle) |
50 |
Dilute HCl, pH 1.1 for first 2 hrs, then add 200 mL of 200 mM Phosphate Buffer and adjust to pH 6.0 for the remainder |
0-2 hrs: 750 mL. After 2 hrs: 950 mL |
0.5, 1, 2, 3, and 4 hours |
2007/07/25 |
| Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate [12.5, 25, 37.5, 50 mg] |
Capsule (Extended Release) |
II (Paddle) |
50 |
Media 1: pH 1.1±0.1, Dilute HCl 2 hours; Media 2: pH 6.0±0.1, Phosphate Buffer 3rd hour, Media 3: pH 7.5±0.1, Phosphate Buffer for the remainder |
Media 1: 750 mL; Media 2: 950 mL; Media 3: 1000 mL |
0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours |
2017/11/16 |
| Amphetamine ER |
Capsule |
II (Paddle) |
50 |
750 ml of dilute HCl, pH 1.1 for the first 2 hours, then add 200 ml of 200 mM phosphate buffer, and adjust to pH 6 (w/ HCl or NaOH) for the remainder |
750 ml of dilute HCl, 200 ml of phosphate buffer |
1, 2, 3, 4, and 6 hours |
2006/08/17 |
| Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate |
Tablet (Extended Release) |
II (Paddle) |
50 |
Stage 1: 500 mL of water for 1 hour; Stage 2: 700 mL of 0.001N HCl for next 2 hours (add 200 mL of HCl to Stage 1); Stage 3: 900 mL of Phosphate Buffer, pH 6.8 (add 200 mL of Potassium Phosphate Buffer to Stage 2) |
Stage 1: 500; Stage 2: 700; Stage 3: 900 |
1, 3, 3.17, 3.25, 3.5, 3.75, 4, 6, 8 and 12 hours |
2022/05/12 |
| Amphotericin B |
Injectable (Liposomal) |
|
|
Develop a method to characterize in vitro release |
|
|
2016/07/28 |
| Ampicillin/Ampicillin Trihydrate |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Ampicillin/Ampicillin Trihydrate |
for Oral Suspension |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Amprenavir |
Capsule |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 15, 30, and 45 |
2008/02/19 |
| Anagrelide HCl |
Capsule |
I (Basket) |
100 |
0.1 N HCl |
900 |
5, 10, 15, 30 and 45 |
2004/01/14 |
| Anastrozole |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Apalutamide |
Tablet |
II (Paddle) |
75 |
0.25% sodium lauryl sulfate (SLS) in 0.05 M Sodium Phosphate Buffer, pH 4.5 (60 mg strength); 0.5% sodium lauryl sulfate (SLS) in 0.05 M Sodium Phosphate Buffer, pH 4.5 (240 mg strength) |
900 |
5, 10, 15, 20, 30, and 45 |
2024/02/16 |
| Apixaban |
Tablet |
II (Paddle) |
75 |
0.05 M Sodium Phosphate Buffer with 0.05% SLS, pH 6.8 |
900 |
5, 10, 20, 30 and 45 |
2013/05/09 |
| Apomorphine HCl |
Film (Sublingual) |
V (paddle over disk) |
75 |
20mM BIS-TRIS HCl Buffer, pH 6.4 |
500 |
2.5, 5, 7.5, 10, 12.5, 15 and 20 |
2021/08/19 |
| Apremilast |
Tablet |
II (Paddle) |
60 |
0.15% SLS in 25 mM Sodium Phosphate Buffer, pH 6.8 |
900 |
10, 15, 20, 30, and 45 |
2017/05/18 |
| Aprepitant |
For Oral Suspension |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Aprepitant |
Emulsion |
|
|
Develop a method to characterize in vitro release |
|
|
2024/02/05 |
| Aprepitant |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Aripiprazole |
Tablet (Orally Disintegrating) |
II (Paddle) |
75 |
Acetate Buffer, pH 4.0 |
1000 |
10, 20, 30 and 45 |
2008/08/11 |
| Aripiprazole |
Suspension (Extended Release) |
IV (Flow through Cell) with closed system |
4 mL/min |
Acetate buffer, pH 5.0 |
1000 |
0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 14, 16 and 18 hours |
2024/11/01 |
| Aripiprazole |
Tablet |
|
|
Refer to USP |
|
|
2016/06/30 |
| Aripiprazole |
For Intramuscular Suspension (Extended Release) |
II (Paddle) |
50 |
0.25% Sodium Dodecyl Sulfate (SDS) Solution |
900 |
10, 15, 30, 60, 120, 180, 240, 300, 360, 420 and 480 |
2015/06/25 |
| Armodafinil |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 20, 30 and 45 |
2008/01/14 |
| Asciminib HCl |
Tablet |
II (Paddle) |
60 |
Citrate Buffer, pH 3.0 |
900 |
5, 10, 15, 20 and 45 |
2023/10/06 |
| Asenapine |
Transdermal |
VI (Cylinder) |
50 |
pH 5.1 Acetate Buffer at 32°C |
900 |
1, 2, 3, 4, 6, 8, 10 and 12 hours |
2021/04/22 |
| Asenapine Maleate |
Tablet (Sublingual) |
II (Paddle) |
50 |
Acetate Buffer, pH 4.5 |
500 |
1, 2, 3, 4 and 5 |
2013/05/09 |
| Aspirin |
Capsule (Extended Release) |
II (Paddle) with sinker |
100 |
0.05M Potassium Phosphate Buffer (pH 7.4) with trypsin (.001%w/v) and sodium azide (.025% w/v) |
900 |
1, 2, 3, 6, 9, 12, 16, 22 and 30 hours |
2016/10/20 |
| Aspirin |
Capsule |
|
|
Refer to USP |
|
|
2015/05/28 |
| Aspirin/ Omeprazole |
Tablet (Delayed Release) |
I (Basket) |
100 |
Acid Stage: 0.1 N HCl (degassed); Buffer Stage: Phosphate Buffer, pH 6.8 (degassed) |
Acid Stage: 900; Buffer Stage: 900 |
Acid Stage:120; Buffer Stage:10, 20, 30, 45, 60 and 75 |
2016/12/22 |
| Aspirin/Butalbital/Caffeine |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Aspirin/Butalbital/Caffeine |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Aspirin/Butalbital/Caffeine/Codeine Phosphate |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Aspirin/Caffeine/Orphenadrine Citrate |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Aspirin/Dipyridamole |
Capsule |
I (Basket) |
100 |
0.01 N HCl for first hour, 0.1 M Phosphate Buffer, pH 5.5, thereafter |
0-1 hrs: 900 mL. 900 mL thereafter |
Acid: 10, 20, 30, 45 and 60 min; Buffer:1, 2, 5, and 7 hours |
2007/10/09 |
| Aspirin/Hydrocodone Bitartrate |
Tablet |
II (Paddle) |
75 |
Acetate Buffer, pH 4.5 |
900 |
10, 20, 30, 45, 60 and 90 |
2004/01/15 |
| Aspirin/Meprobamate |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Aspirin/Methocarbamol |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Aspirin/Oxycodone HCl |
Tablet |
|
|
Refer to USP |
|
|
2010/01/15 |
| Atazanavir Sulfate |
Capsule |
II (Paddle) |
50 |
0.025 N HCl |
1000 |
10, 20, 30 and 45 |
2006/01/20 |
| Atazanavir Sulfate/ Cobicistat |
Tablet |
II (Paddle) |
75 |
0.05 M Citrate Buffer (pH 2.8) |
1000 |
Atazanavir: 10, 15, 20, 30 and 45; Cobicistat: 5, 10, 15, 20 and 30 |
2015/12/24 |
| Atenolol |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Atenolol/Chlorthalidone |
Tablet |
|
|
Refer to USP |
|
|
2014/02/14 |
| Atogepant |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2023/05/18 |
| Atomoxetine HCl |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Atorvastatin Calcium |
Suspension |
II (Paddle) |
75 |
0.05 M Phosphate Buffer, pH 6.8 |
900 |
5, 10, 15 and 30 |
2024/05/31 |
| Atorvastatin Calcium |
Tablet |
II (Paddle) |
75 |
0.05 M Phosphate buffer, pH 6.8 |
900 |
5, 10, 15 and 30 |
2004/01/15 |
| Atorvastatin Calcium/Ezetimibe |
Tablet |
II (Paddle), with option to use a sinker for 20/10 mg strength |
75 |
Phosphate buffer, pH 6.8 with 0.2% w/v Tween 80 |
900 |
5, 10, 15, 20, 30 and 45 |
2014/05/15 |
| Atovaquone |
Oral Suspension |
|
|
Develop a dissolution method |
|
|
2009/07/21 |
| Atovaquone |
Tablet |
II (Paddle) |
50 |
40% isopropanol buffered to pH 8.0 with potassium dihydrogen phosphate |
900 |
10, 20, 30, 45, 60 and 90 |
2007/06/18 |
| Atovaquone/Proguanil HCl |
Tablet |
II (Paddle) with PEAK vessels |
50 |
40% isopropranol buffered to pH 8.0 with potassium dihydrogen phosphate |
900 |
15, 30, 45 and 60 |
2006/08/17 |
| Atropine Sulfate/ Diphenoxylate HCl |
Tablet |
|
|
Develop dissolution method(s) to characterize the dissolution of both components |
|
|
2016/12/22 |
| Auranofin |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Avacopan |
Capsule |
II (Paddle) with sinker |
50 |
0.1N HCl |
900 |
10, 20, 30, 45 and 60 |
2023/10/06 |
| Avanafil |
Tablet |
II (Paddle) |
50 |
Simulated gastric fluid without pepsin. |
900 |
5, 10, 15, 20 and 30 |
2015/04/02 |
| Avapritinib |
Tablet |
II (Paddle) |
75 |
0.05 M Sodium Acetate Buffer, pH 5.0 containing 0.5% w/v cetyl trimethylammonium bromide (CTAB) |
900 |
5, 10, 15, 20, 30, 45, 60, 90 and 120 |
2022/05/12 |
| Axitinib |
Tablet |
II (Paddle) |
75 |
0.01 N HCl |
900 |
5, 15, 30, 45 and 60 |
2014/08/14 |
| Azacitidine |
Tablet |
II (Paddle) |
75 |
50 mM phosphate buffer, pH 6.8 |
500 |
5, 10, 15, 20, 30 and 45 |
2023/11/30 |
| Azacitidine |
Injectable Suspension |
|
|
Develop a dissolution method |
|
|
2008/09/03 |
| Azathioprine |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Azilsartan Kamedoxomil |
Tablet |
II (Paddle) |
50 |
Phosphate Buffer, pH 7.8 (deaerated) |
900 |
5, 10, 15, 20, 30 and 45 |
2013/05/09 |
| Azilsartan Kamedoxomil/Chlorthalidone |
Tablet |
II (Paddle) |
50 |
Phosphate Buffer, pH 6.8 containing 1.0% Tween 80, |
900 |
5, 10, 15, 20, 30 and 45 |
2013/05/09 |
| Azithromycin |
Tablet |
|
|
Refer to USP |
|
|
2016/12/22 |
| Azithromycin |
Capsule |
|
|
Refer to USP |
|
|
2016/12/22 |
| Azithromycin |
Oral Suspension |
II (Paddle) |
50 |
Phosphate buffer, pH 6.0 |
900 |
10, 20, 30, and 45 |
2006/08/17 |
| Azithromycin |
Suspension (Extended Release) |
II (Paddle) |
50 |
Phosphate Buffer, pH 6.0 |
900 |
15, 30, 45, 60, 120 and 180 |
2008/04/15 |
| Baclofen |
Tablet (Orally Disintegrating) |
II (Paddle) |
25 |
50 mM Acetate Buffer, pH 4.5 |
500 mL (10 mg) or 1000 mL (20mg) |
5, 10, 15 and 30 |
2008/07/14 |
| Baclofen |
Suspension |
II (Paddle) |
25 |
0.01 N HCl |
500 |
5, 10, 15, 30, 45 and 60 |
2024/05/31 |
| Baclofen |
Granules |
II (Paddle) |
50 |
0.01 N HCl |
500 |
5, 10, 15 and 30 |
2024/02/05 |
| Baclofen |
Tablet |
|
|
Refer to USP |
|
|
2009/12/15 |
| Baloxavir Marboxil |
For Suspension |
II (Paddle) |
25 |
Phosphate Buffer, pH 6.8 containing 0.16% w/v cetyl trimethylammonium bromide (CTAB) |
900 |
5, 10, 15, 20 and 30 |
2023/02/09 |
| Baloxavir Marboxil |
Tablet |
II (paddle) |
50 |
20 mg: Phosphate Buffer, pH 6.8 with 0.07% w/v (CTAB); 40 mg: Phosphate Buffer, pH 6.8 with 0.16% w/v CTAB; 80 mg: Phosphate Buffer, pH 6.8 with 0.40 w/v cetyltrimethylammonium bromide (CTAB) |
900 |
5, 10, 15, 20, 30 and 45 |
2023/07/07 |
| Balsalazide Disodium |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Balsalazide Disodium |
Capsule |
II (Paddle) with sinker |
50 |
pH 6.8 buffer |
900 |
10, 20, 30, and 45 |
2006/01/26 |
| Baricitinib |
Tablet |
II (Paddle) |
75 |
Acetate buffer pH 4.5 |
900 |
5, 15, 30, 45 |
2023/03/30 |
| Bedaquiline Fumarate |
Tablet |
I (Basket) |
150 |
0.01 N HCl |
900 |
10, 15, 20, 30 and 45 |
2013/06/06 |
| Belzutifan |
Tablet |
II (Paddle) |
50 |
50 mM potassium phosphate buffer at pH 6.5 with 68 mM potassium chloride (@37°C) |
900 |
10, 15, 20, 30, 45 and 60 |
2023/07/07 |
| Bempedoic Acid |
Tablet |
II (Paddle) |
50 |
0.05 M Phosphate buffer, pH 6.6 |
900 |
5, 10, 15, 20 and 30 |
2021/08/19 |
| Bempedoic Acid/Ezetimibe |
Tablet |
II (Paddle) |
50 |
Bempedoic Acid: 0.05 M Phosphate buffer, pH 6.6; Ezetimibe: 0.05M Sodium
Acetate Buffer pH 4.5 with 0.45% SLS |
900 |
5, 10, 15, 20, 30, and 45 |
2021/08/19 |
| Benazepril HCl |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Benazepril HCl/Hydrochlorothiazide |
Tablet |
I (Basket) |
100 |
0.1 N HCl |
500 |
10, 20, 30 and 45 |
2004/01/16 |
| Bendroflumethiazide/Nadolol |
Tablet |
|
|
Refer to USP |
|
|
2007/07/25 |
| Benzonatate |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Benzoyl Peroxide; Clindamycin Phosphate |
Gel |
|
|
Develop a method to characterize in vitro release |
|
|
2023/05/18 |
| Benzphetamine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Bepridil HCl |
Tablet |
I (Basket) |
100 |
0.1 N HCl |
900 |
10, 20, 30, 45 and 60 |
2004/01/16 |
| Berotralstat HCl |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2023/02/09 |
| Betamethasone Acetate/Betamethasone Sodium Phosphate |
Injectable Suspension |
IV (Flow through cell) |
Flow @ 8 mL/min |
0.05% SLS, pH 3.0 or Develop an in vitro release method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency |
|
5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, and 360 |
2010/04/08 |
| Bethanechol Chloride |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Bethanechol Chloride |
Tablet |
|
|
Refer to USP |
|
|
2008/10/06 |
| Betrixaban |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Bexagliflozin |
Tablet |
I (Basket) |
50 |
0.1 N HCl |
900 |
1, 3, 5, 8 and 10 hours |
2024/05/31 |
| Bexarotene |
Capsule |
II (Paddle) |
50 |
Tier 1 Medium: 0.5% HDTMA in 0.05 M phosphate buffer, pH 7.5
Tier 2 Medium: 0.5% HDTMA in 0.05 M phosphate buffer, pH 7.5 with 0.05 g/L pancreatin enzyme |
900 |
15, 30, 45 and 60 |
2006/08/17 |
| Bicalutamide |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate |
Tablet |
II (Paddle) |
75 |
50 mM Citrate buffer, pH 5.5 |
900 |
5, 10, 15, 20, 30, 45 and 60 |
2024/11/01 |
| Bimatoprost |
Implant |
|
|
Develop a method to characterize in vitro release |
|
|
2023/07/07 |
| Bisacodyl/Polyethylene glycol 3350/ Potassium Chloride/Sodium Bicarbonate/ Sodium Chloride |
Tablet (Delayed Release), For Solution, |
II (Paddle) |
100 |
Acid stage: 0.1 N HCl: Buffer stage: 0.05 M Phosphate buffer, pH 6.8, with 0.15% sodium lauryl sulfate (SLS) [only for Bisacodyl Tablets] |
Acid stage: 900 mL; Buffer stage: 900 mL |
Acid stage: 60; Buffer stage: 10, 20, 30, 45 and 60 |
2017/03/02 |
| Bismuth Subcitrate Potassium/Metronidazole/Tetracycline HCl |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Bismuth Subsalicylate (BiSub)/Metronidazole (Met)/Tetracycline HCl (Tet) |
BiSub: Tablet (Chewable) /Met:Tablet /Tet: Capsule |
II (Paddle) |
50 |
BiSub: 0.1 N HCl /Met: Refer to USP /Tet: Refer to FDA's Dissolution Guidance, 2018 |
900 |
5, 10, 15, 20 and 30 |
2022/07/07 |
| Bisoprolol Fumarate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Bisoprolol Fumarate/Hydrochlorothiazide |
Tablet |
II (Paddle) |
75 |
0.1 N HCl |
900 |
5, 10, 20, 30 and 45 |
2004/01/20 |
| Boceprevir |
Capsule |
II (Paddle) with sinker |
50 |
50 mM phosphate buffer, pH 6.8 with 0.1% sodium dodecyl sulfate |
900 |
10, 20, 30, 45, 60 and 75 |
2013/01/31 |
| Bosentan |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Bosentan |
Tablet (For Suspension) |
II (Paddle) |
75 |
0.1 N HCl with 0.5% sodium dodecyl sulfate (SDS), pH 1.1 |
900 |
5, 10, 15, 20 and 30 |
2017/11/16 |
| Bosutinib Monohydrate |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 15, 20, 30 and 45 |
2015/06/25 |
| Brexpiprazole |
Tablet |
II (Paddle) |
50 |
0.05 M Acetate buffer, pH 4.3 |
900 |
10, 15, 20, 30 and 45 |
2016/10/20 |
| Brigatinib |
Tablet |
II (Paddle) |
70 |
50 mM Potassium Phosphate Buffer, pH 7.2 |
900 |
5, 10, 15, 20, 30 and 45 |
2017/11/02 |
| Brimonidine Tartrate/Brinzolamide |
Ophthalmic Suspension |
|
|
Develop a method to characterize in vitro release |
|
|
2015/01/15 |
| Brincidofovir |
Tablet |
I (Basket) |
50 |
50 mM sodium phosphate buffer, pH 6.4 + 0.3% SDS |
900 |
5, 10, 15, 20, 30, 45, 60, 75 and 90 |
2023/07/07 |
| Brincidofovir |
Suspension |
II (Paddle) |
50 |
0.05 M Sodium Phosphate Monobasic, Monohydrate Buffer, pH 6.4 + 0.05% Tween 80 |
900 |
5, 10, 15, 20, 30, 45, 60, 75 and 90 |
2023/07/07 |
| Brinzolamide |
Ophthalmic Suspension |
|
|
Develop a method to characterize in vitro release |
|
|
2011/09/01 |
| Brivaracetam |
Tablet |
II (Paddle |
50 |
Phosphate Buffer, pH 6.4 |
2.5 and 5 mg tablets: 500 mL; 10, 25, 50, 75 and 100 mg tablets: 900 mL |
5, 10, 15, 20 and 30 |
2016/07/28 |
| Bromocriptine Mesylate |
Tablet |
|
|
Refer to USP |
|
|
2007/07/25 |
| Budesonide |
Capsule |
II (Paddle) with sinker |
75 |
Acid stage: 0.1 N HCl; Buffer stage: Phosphate Buffer, pH 7.5 |
Acid stage: 1000; Buffer stage: 1000 |
Acid stage: 2 hours; Buffer stage: 0.25, 0.5, 1, 2, 4, 6 and 8 hours |
2015/02/25 |
| Budesonide |
Tablet (Extended Release) |
II (Paddle) |
100 |
Acid Stage: 0.1 M HCl containing
0.5% Macrogol Cetostearyl Ether; Buffer Stage: pH 7.2 phosphate buffer containing 0.5% Macrogol
Cetostearyl Ether. |
Acid Stage: 500 mL ; Buffer Stage: 1000 mL |
Acid Stage: 2 hours; Buffer Stage: 1, 2, 4, 6, 8 and 10 hours |
2015/04/02 |
| Bumetanide |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Bupivacaine |
Solution (Extended Release), Infiltration |
II (Paddle) |
50 |
0.025 M Sodium Phosphate Buffer with 0.03% Sodium Dodecyl Sulfate (SDS), pH 7.4 |
900 |
1, 2, 4, 8, 12, 16, 24, 36 and 48 hours |
2022/07/07 |
| Buprenorphine |
Film, Transdermal (Extended Release) |
VI (Cylinder) with adapter, if needed |
50 |
0.9% Sodium Chloride at 32°C |
600 |
0.5,1, 2, 4, 6, 8,12, 16 and 24 hours |
2013/05/09 |
| Buprenorphine HCl |
Film (Buccal) |
I (Basket) 100 mL round bottom vessel |
100 |
0.05M NaH2PO4.H2O Phosphate Buffer, pH 4.5 |
60 |
10, 15, 20, 30, 45 and 60 |
2016/10/20 |
| Buprenorphine HCl |
Implant |
II (Paddle) |
50 |
Water |
900 |
1, 4, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours |
2016/07/28 |
| Buprenorphine HCl |
Tablet (Sublingual) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Buprenorphine HCl/Naloxone HCl |
Film (Sublingual) |
V (Paddle over Disk) with 56 mm, 40 mesh stainless steel disk. |
100 |
Acetate Buffer, pH 4.0 (12.5mM Sodium acetate trihydrate and 60mM glacial acetic acid. Adjust the pH with glacial acetic acid or ammonium hydroxide). |
900 |
1, 2, 3, 5, 7 and 10 |
2013/10/31 |
| Buprenorphine HCl/Naloxone HCl |
Tablet (Sublingual) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Bupropion HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Bupropion HCl |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Bupropion Hydrobromide |
Tablet (Extended Release) |
I (Basket) |
75 |
0.1 N HCl |
900 |
1, 2, 4, 6, 8 and 10 hours |
2009/06/10 |
| Buspirone Hydrochloride |
Capsule |
II (Paddle) |
50 |
0.01 N HCl |
500 |
10, 20, 30 and 45 |
2024/11/01 |
| Buspirone Hydrochloride |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Busulfan |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Busulfan |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Cabergoline |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Cabotegravir |
Suspension (Extended Release) |
II (Paddle) |
20 |
0.5% w/v cetyltrimethylammonium bromide (CTAB) in 140 mM McIlvaine buffer, pH 7.4 |
1000 |
5, 10, 20, 30, 45 and 60 |
2023/07/07 |
| Cabotegravir (CABO); Rilpivirine (RILP) |
Suspension, Extended release |
II (Paddle) |
20 (CABO); 50 (RILP) |
0.5% w/v solution of cetyltrimethylammonium bromide (CTAB) in 140 mM McIlvaine buffer, pH 7.4 (CABO); 6.0% w/v Polysorbate 20 in 0.05 M Sodium Phosphate buffer, pH 7.4 (RILP) |
|
5, 10, 15, 20, 30, 45 and 60 (CABO); 5, 30, 90 and 360 (RILP) |
2023/05/18 |
| Cabotegravir Sodium |
Tablet |
II (Paddle) |
60 |
0.01N HCl with 0.2% cetyltrimethylammonium bromide (CTAB) |
1000 |
5, 10, 15, 20, 25 and 30 |
2022/07/07 |
| Cabozantinib S-Malate |
Tablet |
II (Paddle |
75 |
0.01 N HCl with 0.375% Triton X-100 (degassed) |
900 |
5, 10, 15, 20 and 30 |
2016/07/28 |
| Cabozantinib S-Malate |
Capsule |
II (Paddle) with sinker |
75 |
0.01 N HCl with 0.5% Triton X-100 (degassed) |
900 |
5, 10, 15, 20 and 30 |
2016/06/02 |
| Caffeine; Ergotamine Tartrate |
Suppository |
II (Paddle) |
50 |
1% Tartaric Acid |
900 |
10, 15, 30, 35, 40 and 45 |
2024/02/05 |
| Calcifediol |
Capsule (Extended Release) |
II (Paddle) with sinker |
75 |
0.5% SDS in 5 mM Sodium Dihydrogenphosphate Monohydrate, pH 6.8 |
500 |
1, 2, 4, 6, 8, 10 and 12 hours |
2016/10/20 |
| Calcitriol |
Capsule |
|
|
Develop a quantitative rupture test |
|
|
2008/06/03 |
| Calcium Acetate |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Calcium Acetate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Calcium carbonate/Famotidine/ Magnesium hydroxide |
Tablet, Chewable |
III (Reciprocating Cylinder) |
|
0.1 M Sodium Acetate, pH 4.5 |
900 |
5,10, 15, 20, 30 and 45 |
2023/03/30 |
| Canagliflozin |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Canagliflozin (Can)/ Metformin HCl (Met) |
Tablet (Extended Release) |
Met: I (Basket, 40 mesh): Can: I (Basket, 10 mesh [with option of tablet holder]) |
Met: 100: Can:100 |
Met: Simulated Gastric Fluid [SGF] without enzyme, pH 1.2; Can: 0.1% (w/v) polysorbate 20 in 0.05 M sodium phosphate buffer pH 6.8 ( 50 mg); 0.2% (w/v) polysorbate 20 in 0.05 M sodium phosphate buffer pH 6.8 (150 mg) |
Met: 900: Can: 900 |
Met: 1, 2, 4, 6, 8 10 and 12 hours: Can: 10, 15, 20, 30, 45 and 60 minutes; |
2016/12/22 |
| Canagliflozin/Metformin HCl |
Tablet |
II (Paddle) |
Canagliflozin: 75; Metformin: 50 |
Canagliflozin (50 mg): 0.025 %
Polysorbate 20; Canagliflozin (150 mg):0.075 %
Polysorbate 20; Metformin: Phosphate
buffer, pH 6.8 |
Canagliflozin (50 mg): 900; Canagliflozin (150 mg): 900 ; Metformin: 1000 |
Canagliflozin: 10, 15, 20, 30 and 45; Metformin: 5, 10, 15, 20 and 30 |
2015/05/28 |
| Candesartan Cilexetil (16 mg, 8 mg and 4 mg) |
Tablet |
II (Paddle) |
50 |
0.35% Polysorbate 20 in 0.05 M Phosphate Buffer, pH 6.5 |
900 |
10, 20, 30, 45 and 60 |
2007/06/20 |
| Candesartan Cilexetil (32 mg) |
Tablet |
II (Paddle) |
50 |
0.70% Polysorbate 20 in 0.05 M Phosphate Buffer, pH 6.5 |
900 |
10, 20, 30, 45 and 60 |
2007/06/20 |
| Candesartan Cilexetil/Hydrochlorothiazide (16/12.5 mg) |
Tablet |
II (Paddle) |
50 |
0.35% Polysorbate 20 in phosphate buffer pH 6.5 |
900 |
10, 20, 30, 45 and 60 |
2010/01/29 |
| Candesartan Cilexetil/Hydrochlorothiazide (32/12.5 mg and 32/25 mg) |
Tablet |
II (Paddle) |
50 |
0.70% Polysorbate 20 in phosphate buffer pH 6.5 |
900 |
15, 20, 30, 45 and 60 |
2010/01/29 |
| Capecitabine |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Capmatinib HCl |
Tablet |
I (Basket) |
75 |
0.01N HCl (degassed) |
900 |
5, 10, 15, 20, 30 and 45 |
2022/05/12 |
| Captopril |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Carbamazepine |
Capsule (Extended Release) |
II (Paddle) |
75 |
First 4 hours: Dilute Acid, pH 1.1. After 4 hours: Phosphate Buffer, pH 7.5 with 0.1% sodium lauryl sulfate (SLS). |
First 4 h: 900. After 4 h: 900 |
1, 2, 4, 6, 8, 10 and 12 hours |
2011/09/01 |
| Carbamazepine |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Carbamazepine |
Tablet (Chewable) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Carbamazepine |
Suspension |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Carbamazepine |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Carbidopa |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Carbidopa/Entacapone/Levodopa |
Tablet |
I (Basket) |
Carbidopa and Levodopa: 50; Entacapone: 125 |
For both Carbidopa and Levodopa: 0.1 N HCl, For Entacapone: Phosphate buffer pH 5.5 |
Carbidopa and Levodopa: 750 ml. Entacapone: 900 ml |
10, 20, 30, 45 and 60 |
2007/01/03 |
| Carbidopa/Levodopa |
Suspension (Enteral) |
II (Paddle) |
25 |
0.05 M Sodium Acetate Buffer, pH 4.5 |
500 |
5, 10, 15, 20, 30, 40 and 60 |
2016/10/20 |
| Carbidopa/Levodopa |
Tablet (Extended Release) |
II (Paddle) |
50 |
0.1 N HCl |
900 |
0.5, 0.75, 1, 1.5, 2, 2.5, 3 and 4 hours |
2013/08/15 |
| Carbidopa/Levodopa |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2021/04/22 |
| Carbidopa/Levodopa |
Capsule (Extended Release) |
I (Basket) |
75 |
Acid stage: Simulated Gastric Fluid [SGF] without enzyme; Buffer stage: pH 7.0, 50 mM Phosphate Buffer |
Acid stage: 500 mL [for 23.75/95 mg strength], 900 mL [other strengths]; Buffer stage:500 mL [for 23.75/95 mg strength], 900 mL [other strengths] |
Acid stage: 30, 60 and 120; Buffer stage: 15, 30, 60, 90, 120, 180 and 240 |
2016/04/07 |
| Carbidopa/Levodopa |
Tablet (Orally Disintegrating) |
II (Paddle) |
50 |
0.1 N HCl |
750 |
5, 10, 15, 30, and 45 |
2007/07/25 |
| Carbinoxamine Maleate |
Suspension (Extended Release) |
II (Paddle) |
50 |
0.4 M Phosphate Buffer |
900 [ 895 mL 0.4 M Buffer +5 mL Suspension] |
0.5, 1, 2, 3, 4, 6, 8 and 12 hours |
2016/06/02 |
| Carbinoxamine Maleate |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Carglumic Acid |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Cariprazine HCl |
Capsule |
I (Basket) |
100 |
Sodium Acetate Buffer, pH 5.0 (degas) |
500 |
5, 10, 15, 20, 30 and 45 |
2016/06/30 |
| Carisoprodol |
Tablet |
|
|
Refer to USP |
|
|
2010/01/29 |
| Carvedilol |
Tablet |
|
|
Refer to USP |
|
|
2015/12/24 |
| Carvedilol |
Tablet |
II (Paddle) |
50 |
SGF without enzyme |
900 |
10, 20, 30 and 45 |
2004/01/21 |
| Carvedilol Phosphate |
Capsule (Extended Release) |
II (Paddle) |
100 |
0.1 N HCl |
900 |
1, 2, 4, 6, 8, 12, 18 and 24 hours |
2013/10/31 |
| Cedazuridine/Decitabine |
Tablet |
II (Paddle) |
75 |
50 mM phosphate buffer, pH 6.8 |
900 |
5, 10, 15 and 30 |
2022/07/07 |
| Cefaclor |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Cefaclor |
Tablet (Chewable) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Cefaclor |
Tablet (Extended Release) |
|
|
Refer to USP |
|
|
2011/03/03 |
| Cefadroxil |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Cefadroxil |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Cefadroxil |
Suspension |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Cefdinir |
Capsule |
II (Paddle) |
50 |
Phosphate Buffer, pH 6.8 |
900 |
5, 10, 15, 30 and 45 |
2007/07/25 |
| Cefdinir |
Suspension |
II (Paddle) |
50 |
0.05 M Phosphate buffer, pH 6.8 |
900 |
10, 20, 30 and 45 |
2007/04/09 |
| Cefditoren Pivoxil |
Tablet |
II (Paddle) |
75 |
Simulated Gastric Fluid without enzyme |
900 |
5, 10, 15, 20 and 30 |
2010/01/15 |
| Cefixime |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Cefixime |
Tablet (Chewable) |
II (Paddle |
25 |
Phosphate Buffer, pH 7.2 |
900 |
10, 15, 20, 30, and 45 |
2010/12/23 |
| Cefixime |
Capsule |
I (Basket) |
100 |
0.05 M Phosphate Buffer, pH 7.2 |
900 |
10, 20, 30, 45 and 60 |
2013/08/15 |
| Cefixime |
Suspension |
II (Paddle) |
50 |
0.05 M Phosphate buffer, pH 7.2 |
900 |
10, 20, 30 and 45 |
2007/04/09 |
| Cefpodoxime Proxetil |
Suspension |
II (Paddle) |
50 |
Glycine Buffer (0.04 M) pH 3.0 |
900 |
10, 20, 30 and 45 |
2005/12/20 |
| Cefpodoxime Proxetil |
Tablet |
|
|
Refer to USP |
|
|
2007/07/25 |
| Cefprozil |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Cefprozil |
For Oral Suspension |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Cefprozil Monohydrate |
Suspension |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Ceftibuten Dihydrate |
Suspension |
II (Paddle) |
50 |
0.05 M Phosphate Buffer, pH 7.0 |
1000 |
10, 20, 30 and 45 |
2004/01/21 |
| Cefuroxime Axetil |
Tablet |
|
|
Refer to USP |
|
|
2007/07/25 |
| Celecoxib |
Capsule |
II (Paddle) |
50 mg, 100 mg and 200 mg: 50 rpm; 400 mg: 75 rpm |
Tier 1 Medium: 0.04 M tribasic sodium phosphate (pH 12) with 1% SLS. Tier 2 Initial Medium: 750 mL of simulated gastric fluid, USP (includes pepsin); At 20 minutes, while stirring, add 180 mL of appropriate concentrations of SLS solution (for a final concentration of 1% SLS). Add about 70 mL of 1.2 N NaOH to adjust the pH to 12. |
Tier 1: 1000 mL Tier 2: 750 mL (initial) 1000 mL (final) |
10, 20, 30, 45 and 60 |
2010/07/01 |
| Celecoxib; Tramadol HCl |
Tablet |
II (Paddle) |
75 |
0.1N Hydrochloric Acid + 2% SLS |
1000 |
5, 10, 15, 20, 30, 45 and 60 |
2023/07/07 |
| Cenobamate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2024/08/05 |
| Cephalexin |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Cephalexin |
Suspension |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Ceritinib |
Capsule |
II (Paddle) |
60 |
0.01 N HCl (degassed) |
900 |
5, 10, 15, 20 and 30 |
2015/08/27 |
| Ceritinib |
Tablet |
I (Basket) |
75 |
0.01 N HCl (degassed) |
900 |
5, 10, 15, 20 and 30 |
2021/04/22 |
| Cetirizine |
Capsule (Soft-Gelatin) |
II (Paddle) |
50 |
25 mM pH 6.8 phosphate buffer |
900 |
5, 10, 15, 20, 30 and 45 |
2015/01/15 |
| Cetirizine HCl |
Tablet (Regular & Chewable) |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Cetirizine HCl |
Tablet (Orally Disintegrating) |
|
|
Refer to USP |
|
|
2016/03/17 |
| Cetirizine HCl/Pseudoephedrine HCl |
Tablet (Extended Release) |
I (Basket) |
100 |
0.1 N HCl |
500 |
0.17, 0.25, 0.5, 1, 2, 6 and 8 hours |
2007/06/18 |
| Cevimeline HCL |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Chlorambucil |
Tablet |
II (Paddle) |
75 |
0.1 N HCl |
900 |
10, 20, 30, and 45 |
2006/08/17 |
| Chlordiazepoxide HCl/ Clidinium Bromide |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Chlorhexidine Gluconate |
Tablet (Dental) |
|
|
Develop a method to characterize in vitro release |
|
|
2022/07/07 |
| Chloroquine Phosphate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/04/16 |
| Chlorothiazide |
Suspension |
|
|
Develop a dissolution method |
|
|
2019/03/07 |
| Chlorpheniramine Maleate |
Tablet (Extended Release) |
III (Reciprocating Cylinder) |
27 dpm |
Row 1: Test Fluid 1 (0.1N HCl) for 1st hour. Row 2: Test fluid 2 (Phosphate Buffer, pH 7.5) for 5th hour |
Row 1: 250 mL. Row 2: 250 mL |
1 hour for test fluid 1, and 4 hours for test fluid 2 |
2007/07/25 |
| Chlorpheniramine Maleate/Codeine Phosphate |
Tablet (Extended Release) |
II (Paddle) |
50 |
Simulated gastric fluid (SGF) without enzyme (pH 1.2) |
900 |
0.5, 1, 2, 4, 6, 8 and 12 hours |
2016/10/20 |
| Chlorpheniramine Maleate/Ibuprofen/Phenylephrine HCl |
Tablet |
II (Paddle) |
50 |
50 mM Potassium Phosphate Buffer, pH 6.5 (degassed) |
900 |
5, 10, 15, 20 and 30 |
2015/06/25 |
| Chlorpheniramine Maleate/Ibuprofen/Pseudoephedrine HCl |
Tablet |
II (Paddle) |
50 |
0.05 M Phosphate Buffer, pH 6.5 |
900 |
10, 20, 30 and 45 |
2004/02/20 |
| Chlorpheniramine Polistirex/ Codeine polistirex |
Suspension (Extended Release) |
II (Paddle) |
50 |
Acid Stage: 0.1 N HCl; Buffer Stage: pH 6.8 Phosphate Buffer [500 mL 0.1 N HCl for 1 hour, followed by addition of 400 mL of 0.2M NaH2P04 to pH 6.8] |
Acid Stage: 500 mL; Buffer Stage: 900 mL |
Acid Stage: 1 hour; Buffer Stage: 1, 2, 4, 6, 8 and 12 hours |
2016/03/17 |
| Chlorpheniramine Polistirex/Hydrocodone Polistirex |
Extended Release Oral Suspension |
II (Paddle) |
50 |
Simulated Gastric Fluid (SGF) at 37ºC ± 0.5ºC |
495 |
1, 2, 3, 6, 8, 12, 16 and 24 hours |
2011/06/30 |
| Chlorpheniramine Polistirex/Hydrocodone Polistirex |
Capsule (Extended Release) |
II (Paddle) |
50 |
Simulated Intestinal Fluid without enzyme |
500 |
1, 4, 12, and 24 hours |
2008/11/25 |
| Chlorpromazine HCl |
Tablet |
|
|
Refer to USP |
|
|
2012/01/05 |
| Chlorthalidone |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Chlorzoxazone |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Cholic Acid |
Capsule |
II (Paddle) with sinker |
100 |
Phosphate Buffer, pH 6.8 |
500 mL for 50 mg capsule; 900 mL for 250 mg capsule |
5, 10, 15, 20 and 30 |
2016/03/17 |
| Choline Fenofibrate |
Capsule (Delayed Release) |
II (Paddle) |
50 |
Acid Stage: 0.05M Sodium Phosphate, pH 3.5 ± 0.05; Buffer Stage: 0.05 M Sodium Phosphate, pH 6.8 ± 0.05 |
Acid stage: 500; Buffer stage: 900 |
Acid stage: 120; Buffer stage: 15, 30, 60, 90, 120, 240 and 360 |
2010/07/01 |
| Ciclopirox |
Topical Suspension |
|
|
Develop a method to characterize in vitro release |
|
|
2010/03/25 |
| Cilostazol |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Cimetidine |
Tablet |
|
|
Refer to USP |
|
|
2023/11/30 |
| Cinacalcet HCl |
Tablet |
II (Paddle) |
75 |
0.05 N HCl |
900 |
10, 20, 30 and 45 |
2006/01/26 |
| Ciprofloxacin |
Oral Suspension |
II (Paddle) |
100 |
0.05 M Acetate Buffer with 0.025% Brij35 (polyoxyethylene lauryl ether), pH 4.5 |
900 |
10, 20, 30 and 45 |
2010/03/25 |
| Ciprofloxacin |
Injectable Suspension [Otic] |
IV (Flow through cell-closed loop) / 22 mm |
Flow @ 6 mL/min |
50 mM Acetate Buffer, pH 4.5 @37°C ± 0.5 [use glass beads; sample volume: 100 μl] |
480 |
5, 10, 15, 20, 30, 45, 60
and 75 |
2016/03/17 |
| Ciprofloxacin HCl |
Tablet (Extended Release) |
I (Basket) |
100 |
0.1 N HCl |
900 |
1, 2, 4, and 7 hours or until at least 80% released |
2008/01/14 |
| Ciprofloxacin HCl |
Tablet |
|
|
Refer to USP |
|
|
2010/09/02 |
| Ciprofloxacin HCl/Hydrocortisone |
Otic Suspension |
|
|
Develop a method to characterize in vitro release |
|
|
2011/09/01 |
| Ciprofloxacin/Ciprofloxacin HCl (AB) |
Tablet (Extended Release) |
II (Paddle) |
50 |
0.1 N HCl |
900 |
15, 30, 60, and 120 |
2008/01/14 |
| Ciprofloxacin/Dexamethasone |
Otic Suspension |
|
|
Develop a method to characterize in vitro release |
|
|
2016/03/17 |
| Citalopram |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2023/07/07 |
| Citalopram HBr |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Citalopram Hydrobromide |
Capsule |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 20, 30 and 45 |
2008/10/06 |
| Cladribine |
Tablet |
II (Paddle) |
50 |
Phosphate Buffer, pH 6.8 (deaerated) |
900 |
5, 10, 15, 20 and 30 |
2022/05/12 |
| Clarithromycin |
Suspension |
II (Paddle) |
50 |
0.05 M Phosphate Buffer, pH 6.8 |
900 |
10, 20, 30, 45 and 60 |
2004/01/23 |
| Clarithromycin |
Tablet (Extended Release) |
|
|
Refer to USP |
|
|
2008/10/06 |
| Clarithromycin |
Tablet |
|
|
Refer to USP |
|
|
2007/07/25 |
| Clindamycin HCl |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Clobazam |
Tablet |
II (Paddle) |
75 |
0.1 N HCl (degassed) |
900 |
5, 10, 20, 30, 45 and 60 |
2013/07/31 |
| Clobazam |
Oral Suspension |
II (Paddle) |
75 |
0.1 N HCl (degassed) |
900 |
5, 10, 15, 20, 25 and 30 |
2013/07/31 |
| Clobazam |
Film |
V (Paddle over Disk), with 56 mm, 40 mesh stainless steel disk. |
75 |
0.1 N HCl |
900 |
2, 5, 10, 15, 20 and 30 |
2021/04/22 |
| Clomiphene Citrate |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Clomipramine HCl |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Clonazepam |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Clonazepam |
Suspension |
|
|
Develop a dissolution method |
|
|
2024/11/01 |
| Clonazepam |
Tablet (Orally Disintegrating) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Clonidine |
Transdermal |
|
|
Refer to USP |
|
|
2009/02/18 |
| Clonidine ( 0.1 mg) |
Tablet (Extended Release) |
II (Paddle) with sinker |
50 |
Acid stage: 0.01 N HCl; Buffer stage: Phosphate Buffer, pH 7.0 |
Acid stage: 500; Buffer stage: 500 |
Acid stage: 1 and 2 hours; Buffer stage: 1, 2, 4, 6, 10, 14 and 16 hours |
2012/01/26 |
| Clonidine ( EQ. 0.17 mg and EQ. 0.26 mg) |
Tablet (Extended Release) |
II (Paddle) |
50 |
500 mL 0.1N HCl for the 1st hour, then add 400 mL 0.27M Sodium Phosphate (Dibasic) buffer solution |
Acid stage: 500; Buffer stage: 900 |
1, 2, 3, 6, 9, 12, 16, 20 and 24 hours |
2010/07/01 |
| Clonidine HCl |
Tablet |
|
|
Refer to USP |
|
|
2007/06/18 |
| Clonidine HCl (0.1 mg & 0.2 mg) |
Tablet (Extended Release) |
II (Paddle) with sinker |
50 |
Acid stage: 0.01 N HCl; Buffer stage: Phosphate Buffer, pH 7.0 |
Acid stage: 500; Buffer stage: 500 |
Acid stage: 1 and 2 hours; Buffer stage: 1, 2, 4, 6, 10, 14 and 16 hours |
2015/08/27 |
| Clopidogrel Bisulfate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Clorazepate Dipotassium |
Tablet |
|
|
Refer to USP |
|
|
2013/01/31 |
| Clotrimazole |
Tablet (Vaginal) |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 20, 30 and 45 |
2004/01/24 |
| Clotrimazole |
Lozenge |
|
|
Refer to USP |
|
|
2008/10/06 |
| Clozapine |
Suspension |
II (Paddle) |
50 |
Acetate Buffer (pH 4.0) |
900 |
5, 10, 15, 20 and 30 |
2015/05/28 |
| Clozapine |
Tablet |
|
|
Refer to USP |
|
|
2011/07/21 |
| Clozapine |
Tablet (Orally Disintegrating) |
II (Paddle |
50 RPM (12.5 mg, 25 mg and 100 mg); 75 RPM (150 mg and 200 mg) |
pH 4.5 Acetate Buffer |
900 |
5, 10, 15, 20, and 30 |
2011/06/09 |
| Cobicistat |
Tablet |
II (Paddle) |
75 |
50 mM Sodium Acetate Buffer, pH 4.5 |
900 |
5, 10, 15, 20 and 30 |
2015/08/27 |
| Cobicistat (Cobi)/ Darunavir Ethanolate (Drv) |
Tablet |
Cobi: II (Paddle): Drv: II (Paddle) |
Cobi: 75; Drv:75 |
Cobi: 0.05 M Citrate Phosphate Buffer, pH 4.2; Drv: 0.05 M Sodium Phosphate Buffer, pH 3.0, 2% Tween 20 |
Cobi: 900 mL; Drv: 900 mL |
Cobi: 5, 10, 15, 20 and 30; Drv: 10, 15, 20, 30 and 45 |
2016/10/20 |
| Cobicistat/Elvitegravir/ Emtricitabine/Tenofovir Alafenamide Fumarate |
Tablet |
II (Paddle) |
100 |
0.05 M sodium citrate buffer pH 5.5 containing 2.0% w/v polysorbate 80 |
1000 |
5, 10, 15, 20 and 30 |
2016/10/20 |
| Cobicistat/Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate |
Tablet |
II (Paddle) with sinker |
100 |
0.01 N HCl with 2% w/w Polysorbate 80 |
1000 |
5, 10, 15, 20 and 30 |
2015/06/25 |
| Cobimetinib Fumarate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Codeine Sulfate |
Tablet |
|
|
Refer to USP |
|
|
2011/09/01 |
| Colchicine |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Colchicine |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Colesevelam HCl |
Tablet |
|
|
Disintegration Testing as per USP <701> in various media such as simulated gastric fluid and simulated intestinal fluid. |
|
|
2010/10/28 |
| Crizotinib |
Capsule |
I (Basket) |
100 |
0.1N HCl (degassed) |
900 |
5, 10, 15, 30 and 45 |
2016/04/14 |
| Crofelemer |
Tablet (Delayed Release) |
II (Paddle) |
75 |
Acid stage: 0.1 N HCl; Buffer stage: Sodium phosphate buffer, pH 6.8 |
Acid stage: 750; Buffer stage: 1000 |
Acid stage: 2 hours; Buffer stage: : 5, 10, 20, 30 and 45 minutes |
2016/06/02 |
| Cyclobenzaprine |
Capsule (Extended Release) |
|
|
Refer to USP |
|
|
2016/10/20 |
| Cyclobenzaprine HCl |
Tablet |
|
|
Refer to USP |
|
|
2007/07/25 |
| Cyclophosphamide |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Cycloserine |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Cyclosporine (100 mg) (AB1) |
Capsule (Liquid filled) |
II (Paddle) |
75 |
0.1 N HCl containing 4 mg of N,N-dimethydodecylamine-N-oxide per mL |
1000 |
10, 20, 30, 45, 60 and 90 |
2008/01/14 |
| Cyproheptadine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Cysteamine Bitartrate |
Capsule |
I (Basket) |
75 |
0.1 N HCl |
900 |
10, 20, 30 and 45 |
2004/01/24 |
| Cysteamine Bitartrate |
Capsule (Delayed Release) |
I (Basket) |
75 |
Acid stage: 0.1N HCl;
Buffer stage: 0.05 M Sodium Phosphate buffer, pH 6.8 |
Acid stage: 1000; Buffer stage: 1000 |
Acid stage: 2 hours; Buffer stage: : 5, 10, 15, 20 and 30 minutes |
2015/08/27 |
| Cysteamine Bitartrate |
Granule (Delayed Release) |
I (Basket |
75 rpm (for 75 mg strength); 150 rpm (for 300 mg strength) |
Acid Stage: 0.1 N HCl; Buffer Stage: 0.2M Sodium Phosphate buffer, pH 6.8 |
Acid Stage: 1000; Buffer Stage:1000 |
Acid Stage: 120; Buffer Stage: 5, 10, 15, 20 and 30 |
2020/08/27 |
| Dabigatran Etexilate Mesylate |
Capsule |
I (Basket) for 75 strength: I (Basket with modified diameter of 24.5 mm) for 150 mg strength: |
100 |
0.01 N HCl (pH 2.0) |
900 |
10, 20, 30, and 45 |
2011/09/22 |
| Dabrafenib Mesylate |
Capsule |
II (Paddle) |
65 |
0.2% Cetyl trimethylammonium bromide (CTAB) in 0.1N HCl |
900 |
10, 15, 20, 30 and 45 |
2015/05/28 |
| Daclatasvir Dihydrochloride |
Tablet |
II (Paddle) |
75 |
Phosphate Buffer, pH 6.8 with 0.75% Brij 35 |
1000 |
10, 15, 20, 30 and 45 |
2016/03/17 |
| Dalfampridine |
Tablet (Extended Release) |
II (Paddle) |
50 |
Phosphate Buffer, pH 6.8 |
900 |
0.5, 1, 2, 4, 6, 8, 10 and 12 hours |
2012/06/07 |
| Danazol |
Capsule |
|
|
Refer to USP |
|
|
2007/06/18 |
| Dantrolene Sodium |
Capsule |
I (Basket) |
100 |
0.5% Hyamine 10X in water, adjust to pH 6.8 with 0.1 N KOH or 0.1 N HCl |
900 |
10, 20, 30, 40 and 60 |
2004/01/27 |
| Dantrolene Sodium |
For suspension (Intravenous ) |
II (Paddle) |
50 |
0.5% Benzalkonium Chloride in water |
900 |
0.5, 1, 2, 3, 5 and 10 |
2017/03/02 |
| Dapagliflozin Propanediol |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Dapagliflozin Propanediol/ Metformin HCl |
Tablet (Extended Release) |
I (Basket- 20 mesh) |
100 |
Phosphate Buffer, pH 6.8 |
1000 |
Dapagliflozin: 5, 10, 15, 20, 30 and 45 minutes: Metaformin: 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours |
2015/08/27 |
| Dapagliflozin/Saxagliptin HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/08/27 |
| Daprodustat |
Tablet |
II (Paddle) |
50 |
30 mM Phosphate Buffer, pH 6.8 |
500 for 1 mg; 900 for 2, 4, 6 and 8 mg |
5, 10, 15, 20, 25, 30, 45 and 60 |
2024/05/31 |
| Dapsone |
Gel (Topical) |
|
|
Develop a method to characterize in vitro release |
|
|
2016/07/28 |
| Dapsone |
Tablet |
|
|
Refer to USP |
|
|
2010/12/23 |
| Daridorexant HCl |
Tablet |
II (Paddle) |
75 |
pH 1.2 (NaCl/HCl) |
900 |
5, 10, 15 and 30 |
2023/05/18 |
| Darifenacin Hydrobromide |
Tablet (Extended Release) |
I (Basket) |
100 |
0.01N HCl |
900 |
1, 4, 8, 12, 16, 20 and 24 hours |
2006/01/20 |
| Darolutamide |
Tablet |
II (Paddle) |
75 |
1% sodium lauryl sulfate (SLS) in 0.01N HCl |
1000 |
15, 30, 45, 60, 75 and 90 |
2020/01/30 |
| Darunavir Ethanolate |
Tablet |
II (Paddle) |
75 |
2% Tween-20 in 0.05 M Sodium Phosphate Buffer, pH 3.0 |
900 |
10, 20, 30, and 45 |
2007/09/13 |
| Darunavir Ethanolate |
Oral Suspension |
II (Paddle) |
75 |
0.05% Polysorbate 20 in 0.05M Phosphate Buffer, pH 6.8 |
900 |
5, 10, 15, 20, 30 and 45 |
2015/06/25 |
| Darunavir(Drv)/Cobicistat (Cobi)/Emtricitabine (Emt)/Tenofovir Alafenamide Fumarate (Taf) |
Tablet |
II (Paddle) |
75 |
Drv: 0.05 M Sodium Phosphate Buffer, pH 3.0, 2% Tween 20; For Cobi, Emt and Taf: Citrate Phosphate Buffer, pH 4.2 |
900 |
Drv: 10, 15, 20, 30 and 45; For Cobi, Emt and Taf: 5, 10, 15, 20 and 30 |
2022/07/07 |
| Dasabuvir Na/ Ombitasvir/Paritaprevir/Ritonavir |
Tablet (Extended Release) |
III (Reciprocating Cylinder [40 mesh (for bottom and top of the inner tube)] |
25 dpm |
15 mM hexadecyltrimethylammonium bromide (CTAB) in 0.03M Sodium Phosphate Buffer, pH 6.8 |
250 |
Ombitasvir/ Paritaprevir/ Ritonavir: 10, 15, 20, 30, 45, 60 and 90 minutes;Dasabuvir: 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24 hours |
2016/10/20 |
| Dasatinib |
Tablet |
II (Paddle) |
60 |
pH 4.0 Acetate buffer containing 1% Triton X-100 |
1000 |
10, 15, 30 and 45 |
2009/10/30 |
| Deferasirox |
Granule |
II (Paddle) |
75 |
Phosphate Buffer, pH 6.8 with 0.5% Tween 20 |
900 |
5, 10, 15, 20 and 30 |
2017/11/02 |
| Deferasirox |
Tablet (for Oral Suspension) |
II (Paddle) |
50 |
Phosphate buffer pH 6.8 with 0.5% Tween 20 |
900 |
10, 20, 30 and 45 |
2006/06/21 |
| Deferasirox |
Tablet |
II (Paddle) |
75 |
0.5% Tween 20 in Phosphate Buffer, pH 6.8 |
900 |
5, 10, 15, 20 and 30 |
2016/03/17 |
| Deferiprone |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Deferiprone (1 GM) |
Tablet |
I (Basket) |
100 |
Acidic Stage: 0.1 N HCl, Buffer Stage: 0.05 M Phosphate buffer, pH 6.8. |
|
Acid Stage: 2 hours; Buffer Stage: 1, 2, 3 and 4 hours |
2022/07/07 |
| Deflazacort |
Suspension |
II (Paddle) |
25 |
Simulated Gastric Fluid, pH 1.2 |
500 |
5, 10, 15 and 30 |
2023/07/07 |
| Deflazacort |
Tablet |
II (Paddle) |
50 |
50 mM Phosphate buffer w/0.3% SLS, pH 6.8 |
500 |
5, ,15, 30 and 45 |
2023/07/07 |
| Degarelix Acetate |
Powder for Injection |
|
|
Develop a method to characterize in vitro release |
|
|
2023/10/06 |
| Delafloxacin Meglumine |
Tablet |
II (Paddle) |
60 |
0.05 M Phosphate Buffer, pH 7.4 (degassed) |
900 |
5, 10, 15, 20 and 30 |
2017/11/16 |
| Delavirdine Mesylate |
Tablet |
II (Paddle) |
50 |
0.05 M Phosphate Buffer, pH 6.0 containing 0.6% w/v SDS |
900 |
10, 20, 30, 45 and 60 |
2007/12/03 |
| Demeclocycline HCl |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Demeclocycline HCl |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Desipramine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Desloratadine |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Desloratadine |
Tablet (Orally Disintegrating) |
II (Paddle) |
50 |
0.1 N HCl |
900 |
3, 6, 10, 15 |
2007/06/18 |
| Desloratadine/Pseudoephedrine Sulfate (2.5 mg/120 mg) |
Tablet (Extended Release) |
II (Paddle) |
50 |
First hour: 0.1 N HCl; After 1 hour: 0.1M Potassium Phosphate Buffer pH 7.5 |
1000 |
For Desloratadine: 10, 20, 30 and 45; For Pseudoephedrine Sulfate: 1, 2, 6 and 8 hours |
2009/04/02 |
| Desloratadine/Pseudoephedrine Sulfate (5 mg/240 mg) |
Tablet (Extended Release) |
II (Paddle) |
50 |
First hour: 0.1 N HCl; After 1 hour: 0.1M Potassium Phosphate Buffer pH 7.5 |
1000 |
For Desloratadine: 10, 20, 30 and 45; For Pseudoephedrine Sulfate: 1, 2, 4, 8, 16 and 24 hours |
2009/04/02 |
| Desmopressin Acetate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Desogestrel/Ethinyl Estradiol |
Tablet |
|
|
Refer to USP |
|
|
2008/11/04 |
| Desvenlafaxine Succinate |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Deucravacitinib |
Tablet |
II (Paddle) |
75 |
50 mM potassium phosphate buffer, pH 6.3 with 0.01% (w/v) Brij®35 |
1000 |
10, 20, 30, 45 and 60 |
2023/11/30 |
| Deutetrabenazine |
Tablet |
II (Paddle) over a disk (62 mm with 16 mesh) |
75 |
pH 3.0 Acid Phthalate Buffer |
500 |
0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours |
2017/11/02 |
| Dexamethasone |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Dexamethasone |
Implant (Intravitreal) |
VII (with reciprocating 50 mesh baskets) |
30 cycles per min |
Phosphate Buffered Saline containing 0.05 g/L sodium dodecyl sulfate at 45 ± 0.5°C |
30 |
12, 24, 48, 72, 96, 120, 144, 168, 192, 216 and 240 hours |
2010/10/21 |
| Dexamethasone/Neomycin Sulfate/ Polymyxin B Sulfate |
Ophthalmic Suspension |
|
|
Develop a method to characterize in vitro release |
|
|
2018/02/15 |
| Dexamethasone/Tobramycin |
Ophthalmic Suspension |
|
|
Develop a method to characterize in vitro release |
|
|
2009/04/02 |
| Dexbrompheniramine Maleate/Pseudoephedrine Sulfate |
Tablet (Extended Release) |
III (Reciprocating Cylinder) |
12 dpm |
0.02N HCl (2 hours) followed by
0.05M Phosphate Buffer pH 7.5 |
250 |
0.5, 1, 2, 3, 4, 6 and 8 hours |
2015/05/28 |
| Dexlansoprazole |
Capsule (Delayed Release) |
I (Basket) |
100 |
Acid Stage: 0.1 N HCl, Buffer Stage: pH 7.0 Phosphate Buffer with 5 mM SLS |
Acid Stage: 500; Buffer stage: 900 |
Acid Stage: 120; Buffer Stage: 10, 20, 40, 50, 60 , 75, 105 and 120 |
2010/08/05 |
| Dexlansoprazole |
Tablet (Delayed Release, Orally Disintegrating) |
I (Basket -100 mesh) |
100 |
Acid Stage: 0.1 N HCl; Buffer Stage: pH 7.2 Phosphate Buffer with 5 mM Sodium lauryl sulfate |
Acid Stage: 500 mL; Buffer Stage: 900 mL |
Acid Stage: 120; Buffer Stage: 10, 15, 20, 30, 50, 60, 75 and 90 |
2016/07/28 |
| Dexmedetomidine HCl |
Sublingual Film |
V (Paddle over disk) |
50 |
Simulated saliva |
500 |
5, 10, 15, 20 and 30 |
2023/05/31 |
| Dexmethylphenidate HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Dexmethylphenidate HCl |
Capsule (Extended Release) |
I (Basket) |
100 |
First 2 hours: 0.01 N HCl, Hours 2-10: Phosphate Buffer, pH 6.8 |
Acid: 500, Buffer: 500 |
0.5, 1, 2, 4, 6, and 10 hours |
2008/01/14 |
| Dexmethylphenidate HCl; Serdexmethylphenidate Chloride |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2023/05/18 |
| Dextroamphetamine |
Transdermal System |
VI (Cylinder) |
50 |
50 mM potassium phosphate buffer, pH 6.8 |
|
5, 10, 15, 30, 45, 60, 120, 180, 240, 300 and 360 |
2023/11/30 |
| Dextroamphetamine Sulfate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Dextroamphetamine Sulfate |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Dextroamphetamine Sulfate |
Capsule (Extended Release) |
I ( Basket) |
100 |
0.1 N HCl |
500 |
1, 4, 8 and 12 hours |
2008/11/25 |
| Dextromethophan HBr/Guaifenesin |
Tablet (Extended Release) |
I (Basket) |
50 |
0.01 N HCl |
900 |
1, 2, 6, and 12 hours |
2008/11/25 |
| Dextromethorphan Hydrobromide/Quinidine Sulfate |
Capsule |
I (Basket) |
100 |
pH 1.2, Simulated Gastric Fluid without enzyme |
900 |
5, 10, 15, 20 and 30 |
2012/01/05 |
| Dextromethorphan Polistirex |
Suspension (Extended Release) |
II (Paddle) |
50 |
0.1 N HCl |
500 |
30, 60, 90 and 180 |
2008/10/06 |
| Diazepam |
Tablet |
|
|
Refer to USP |
|
|
2007/07/25 |
| Diazoxide |
Oral suspension |
|
|
Develop a dissolution method |
|
|
2014/02/14 |
| Diclofenac |
Capsule |
I (Basket) |
100 |
10 mM Citrate Buffer pH 5.5 with 0.05% Sodium Dodecyl Sulfate (SDS) |
900 |
5, 10, 20, 30 and 45 |
2015/06/25 |
| Diclofenac Epolamine |
Topical patch |
V (Paddle over Disk) with a watchdish (a diameter of 6 cm) |
50 |
pH 6.8 phosphate buffer at 32 ± 0.5°C |
500 |
15, 30, 45, 60, 90, 120 and 180 |
2010/10/21 |
| Diclofenac Potassium |
Powder for Oral Solution |
II (Paddle |
75 |
0.05M phosphate buffer (TriSodium Phosphate Dodecahydrate in 0.1 N HCl and pH adjusted to 6.8) |
400 |
2.5, 5, 7.5 and 10 |
2010/10/21 |
| Diclofenac Potassium |
Capsule |
II (Paddle |
50 |
50 mM Phosphate buffer pH 6.8 |
900 |
10, 15, 20, 30 and 45 |
2010/10/21 |
| Diclofenac Potassium |
Tablet |
II (Paddle) |
50 |
SIF without enzyme |
900 |
10, 20, 30, 45, 60 and 90 |
2004/01/27 |
| Diclofenac Sodium |
Tablet (Extended Release) |
|
|
Refer to USP |
|
|
2009/06/10 |
| Diclofenac Sodium |
Tablet (Delayed Release) |
|
|
Refer to USP |
|
|
2009/06/10 |
| Diclofenac Sodium/Misoprostol Enteric Coated |
Tablet (Delayed Release) |
II (Paddle)
(diclo) |
100 (diclo) |
Diclofenac:
Acid Stage: 0.1 N HCl
Buffer Stage: 750ml 0.1N HCL+250ml 0.2M phos.buffer, pH 6.8 (Method A)
Misoprostol: Develop a dissolution method |
Diclo: Acid: 750
Buffer:1000 |
Diclo.:
120 (acid)
15, 30, 45 and 60 (Buffer) |
2023/09/15 |
| Dicloxacillin Sodium |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Dicyclomine Hydrochloride |
Tablet |
|
|
Refer to USP |
|
|
2022/05/12 |
| Didanosine |
Tablet (Chewable) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Didanosine |
Capsule (Delayed Release Pellets) |
I (Basket) |
100 |
Acid stage: 0.1 N HCl; Buffer stage: 0.1 N HCl:0.2M Tribasic Sodium Phosphate (3:1), pH 6.8 |
1000 |
Acid stage: 60, 90 and 120; Buffer stage: 10, 20, 30, 45 and 60 |
2004/01/26 |
| Dienogest/Estradiol Valerate |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Diethylpropion HCl |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Diflunisal |
Tablet |
|
|
Refer to USP |
|
|
2008/04/15 |
| Digoxin |
Tablet |
|
|
Refer to USP |
|
|
2007/06/18 |
| Diltiazem HCl |
Tablet (Extended Release) |
II (Paddle) |
100 |
Phosphate Buffer, pH 5.8 |
900 |
2, 8, 14, and 24 hours |
2008/02/19 |
| Diltiazem HCl |
Capsule (Extended Release) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Dimethyl Fumarate |
Capsule (Delayed Release) |
II (Paddle) |
100 |
Acid stage: 0.1 N HCl; Buffer stage: pH 6.8 Phosphate Buffer |
Acid stage: 500; Buffer stage: 500 |
Acid stage: 2 hours; Buffer stage: 5, 10, 20, 30 and 45 |
2016/06/02 |
| Dinoprostone |
Vaginal Suppository |
|
|
Develop a method to characterize in vitro release |
|
|
2012/10/04 |
| Dinoprostone |
Vaginal Insert (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Diphenhydramine Citrate/Ibuprofen |
Tablet |
II (Paddle) |
50 |
50 mM Phosphate Buffer, pH 6.5 |
900 |
10, 20, 30 and 45 |
2008/01/14 |
| Diphenhydramine HCl/Ibuprofen |
Capsule |
I (Basket) |
100 |
200 mM Phosphate Buffer, pH 7.2 |
900 |
10, 20, 30 and 45 |
2008/01/14 |
| Dipyridamole |
Tablet |
|
|
Refer to USP |
|
|
2007/06/18 |
| Diroximel Fumarate |
Capsule (Delayed Release) |
II (Paddle) with sinker |
75 |
Acid Stage: 0.1 N HCl; Buffer Stage: Na.Phosphate Buffer, pH 6.5 |
|
Acid Stage: 120; Buffer Stage: 10, 20, 30, 45, 60, 75 and 90 |
2020/04/02 |
| Disopyramide Phosphate |
Capsule (Extended Release) |
|
|
Refer to USP |
|
|
2008/11/04 |
| Disopyramide Phosphate |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Disulfiram |
Tablet |
II (Paddle) |
100 |
2% SDS |
900 |
15, 30, 45, 60, 75, 90, 105, and 120 |
2007/06/18 |
| Divalproex Sodium |
Tablet (Delayed Release) |
|
|
Refer to USP |
|
|
2007/07/25 |
| Divalproex Sodium |
Tablet (Extended Release) |
|
|
Refer to USP |
|
|
2016/06/30 |
| Divalproex Sodium |
Capsule (Delayed Release) |
|
|
Refer to USP |
|
|
2016/06/30 |
| Dofetilide |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Dolasetron Mesylate |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Dolutegravir Na/Rilpivirine HCl |
Tablet |
II (Paddle) |
75 |
1.0 % Tween 20 in 0.01 M HCl, pH 2.0 |
900 |
10, 15, 20, 30, 45 and 60 |
2018/02/08 |
| Dolutegravir Sodium (10 mg) |
Tablet |
II (Paddle) |
50 |
0.01M pH 6.8 phosphate buffer |
900 |
5, 10, 15, 20, 30 and 45 |
2018/10/18 |
| Dolutegravir Sodium (25 mg) |
Tablet |
II (Paddle) |
50 |
0.01M pH 6.8 phosphate buffer containing 0.15% w/v sodium dodecyl sulfate (SDS) |
900 |
5, 10, 15, 20, 30 and 45 |
2018/10/18 |
| Dolutegravir Sodium (50 mg) |
Tablet |
II (Paddle) |
50 |
0.01M pH 6.8 phosphate buffer containing 0.25% w/v sodium dodecyl sulfate (SDS) |
900 |
5, 10, 15, 20, 30 and 45 |
2018/10/18 |
| Donepezil HCl/Memantine HCl |
Capsule (Extended Release) |
I (Basket) |
100 |
pH 1.2 NaCl/HCl buffer |
900 |
Donepezil: 5, 10, 15, 20 and 30 minutes; Memantine: 1, 2, 3, 4, 6, 8, 10 and 12 hours |
2015/05/28 |
| Donepezil HCl |
Tablet (Orally Disintegrating (ODT)) |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 20, 30 and 45 |
2006/03/04 |
| Donepezil HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Donepezil HCl |
Transdermal |
V (Paddle over disk) with Transdermal System Holding Wire Screen (TSHWR) |
100 |
0.02 M sodium acetate buffer, pH 4.5 at 32°C |
900 |
1,8,24,48 and 168 hours |
2023/05/18 |
| Donepezil HCl (23 mg) |
Tablet |
II (Paddle |
50 |
0.05 M Phosphate Buffer, pH 6.8 |
900 |
1, 2, 3, 4, 6, 8 and 10 hours |
2010/12/23 |
| Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate |
Tablets |
II (Paddle) |
75 |
25 mM Phosphate Buffer, pH 6.8 with 3% Polysorbate 80 |
900 |
5, 10, 15, 20, 30, 45, 60 and 90 |
2023/10/06 |
| Doxazosin Mesylate |
Tablet |
II (Paddle) |
50 |
0.01 N HCl |
900 |
10, 20, 30, 45 and 60 |
2004/01/27 |
| Doxazosin Mesylate |
Tablet (Extended Release) |
II (Paddle) |
75 |
SGF without enzyme |
900 |
1, 2, 4, 6, 8, 12 and 16 hours |
2007/01/03 |
| Doxepin HCl |
Tablet |
II (Paddle) |
50 |
Simulated Gastric Fluid w/o enzyme (pH 1.1-1.3) |
900 |
5, 10, 15, 20, 30 and 45 |
2010/09/02 |
| Doxepin HCl |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Doxepin HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Doxercalciferol |
Capsule |
|
|
Develop a quantitative rupture test |
|
|
2008/06/03 |
| Doxorubicin HCl |
Injectable (Liposomal) |
|
|
Develop a method to characterize in vitro release, starting at pH 6.00 ± 0.05 and at 47ºC ± 0.5ºC. Replicate for 12 dosage vials. |
|
|
2012/10/04 |
| Doxycycline |
Capsule (Delayed Release) |
II (Paddle) |
75 |
Dilute HCl, pH 1.1 for 2 hours and then add 200 mL of 0.1 N NaOH in 200 mM Phosphate Buffer. Adjust pH to 6.0 using 2 N HCl and/or 2N NaOH |
Acid stage: 750; Buffer stage: 950 |
1, 2, 2.5 , 3 and 4 hours |
2008/10/06 |
| Doxycycline |
Suspension |
II (Paddle) |
25 |
0.01 N HCl |
900 |
5, 10, 15 and 20 |
2008/09/03 |
| Doxycycline Calcium |
Suspension |
|
|
Develop a dissolution method |
|
|
2019/03/07 |
| Doxycycline Hyclate |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Doxycycline Hyclate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Doxycycline Hyclate ( 120 mg and 60 mg) |
Tablet (Delayed Release) |
I (Basket) |
100 |
Acid stage: 0.06 N HCl; Buffer stage: Neutralized Phthalate Buffer, pH 5.5 |
Acid stage: 900 mL; Buffer stage: 900 mL |
Acid stage: 10, 20, 30, 45 and 60; Buffer stage: 5, 10, 15, 20, 30 and 45 |
2018/03/27 |
| Doxycycline Hyclate ( 150 mg and 75 mg) |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Doxycycline Hyclate ( 200 mg, 150 mg, 100 mg, 80 mg and 75 mg) |
Tablet (Delayed Release) |
|
|
Refer to USP |
|
|
2015/05/28 |
| Doxycycline Hyclate ( 50 mg) |
Tablet (Delayed Release) |
I (Basket) |
100 |
Acid stage: 0.06 N HCl; Buffer stage: Neutralized Phthalate Buffer, pH 5.5 |
900 |
Acid stage: 5, 10, 15, 20 and 30; Buffer stage: 5, 10, 15, 20 and 30 |
2015/05/28 |
| Doxylamine Succinate/Pyridoxine HCl |
Tablet (Extended Release) |
II (Paddle) |
100 |
Acid stage: 0.1 N HCl: Buffer stage: 0.2M sodium phosphate buffer pH 6.8 |
Acid stage: 1000 mL; Buffer stage: 1000 mL |
Acid stage: 5, 10, 15, 30, 60, 120; Buffer stage: 5, 10, 15, 20 and 30 |
2017/01/19 |
| Dronabinol |
Capsule |
|
|
Develop a dissolution method; (In addition, the USP capsule rupture test should also be conducted) |
|
|
2023/09/15 |
| Dronedarone HCl |
Tablet |
II (Paddle) with sinker |
75 |
pH 4.5 Phosphate buffer |
1000 |
10, 15, 20, 30, 45, 60, 90 and 120 |
2015/02/25 |
| Drospirenone/Estetrol |
Tablet |
II (Paddle) |
50 |
Phosphate Buffer pH 6.8 |
900 |
5,10, 15, 20 and 30 |
2023/03/30 |
| Drospirenone/Estradiol |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Drospirenone/Ethinyl Estradiol |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Drospirenone/Ethinyl Estradiol/Levomefolate Calcium |
Tablet |
II (Paddle) |
50 |
Phosphate buffer pH 6.8, saline with 0.03 % ascorbic acid |
900 |
5, 10, 15, 20 and 30 |
2016/07/28 |
| Droxidopa |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Duetetrabenazine |
Tablet, Extended Release |
II (Paddle) with sinker |
75 |
50 mM potassium biphthalate buffer, pH 3.0 |
500 |
2, 4, 6, 8, 10, 12. 16 and 20 hours |
2023/11/30 |
| Duloxetine HCl |
Capsule (Delayed Release) |
|
|
Refer to USP |
|
|
2016/03/17 |
| Dutasteride |
Capsule (Soft-Gelatin) |
II (Paddle) |
50 |
Tier I: Dissolution Medium: 0.1 N HCI with 2% (w/v) sodium dodecyl sulfate (SDS) (900 mL) Tier II: Dissolution Medium: 0.1 N HCI with pepsin (as per USP) (450 mL) for the first 25 minutes, followed by addition of 0.1 N HCI with SDS (4% w/v) (450 mL) for the remainder of the dissolution test. |
900 |
15, 30, 45 and 60 |
2010/08/05 |
| Dutasteride/Tamsulosin HCl |
Capsule |
Dutasteride: II (Paddle) with sinker. Tamsulosin: II (Paddle) |
Dutasteride: 75 Tamsulosin: 50 |
Dutasteride::Tier I: Dissolution Medium: 1%w/v cetyltrimethylammonium bromide (CTAB) in 0.1 N HCl. Tier II: Dissolution Medium: 1% w/v CTAB in 0.1 N HCl with 0.16% w/v pepsin. Tamsulosin:: Acid Stage (0-2 hrs): 0.1 N HCl. Buffer stage: Add 250 mL of 0.2 M Sodium Phosphate Tribasic, Dodecahydrate pH 6.8 |
Dutasteride: 900. Tamsulosin: Acid stage: 750; Buffer stage: 1000 |
Dutasteride: 15, 30, 45 and 60 minutes. Tamsulosin: Acid Stage: 2 hours Buffer stage: 0.5, 1, 2, 3, 5, 7 and 10 hours |
2012/01/26 |
| Edaravone |
Suspension |
II (Paddle) |
75 |
pH 4.0 Acetate Buffer |
900 |
5, 10, 15, 20 and 30 |
2022/07/28 |
| Efavirenz |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Efavirenz |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Efavirenz 600 mg; Emtricitabine 200 mg; Tenofovir Disoproxil Fumarate 300 mg |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Efavirenz/Lamivudine/Tenofovir Disoproxil Fumarate |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Elacestrant Dihydrochloride |
Tablet |
II (Paddle) |
75 |
0.01 N HCl |
500 for 100 mg; 1000 for 400 mg |
5, 10, 15, 30, 45 and 60 |
2024/05/31 |
| Elagolix Sodium |
Tablet |
II (Paddle) |
50 |
0.05 M Sodium Phosphate, pH 6.8 |
900 |
5, 10, 15, 20, 30 and 45 |
2021/04/22 |
| Elagolix Sodium, Estradiol, Norethindrone Acetate; Elagolix Sodium |
Capsule |
Elagolix: I (Basket) |
Elagolix: 100 |
Elagolix: 0.05M Sodium Phosphate pH 6.8 |
|
10, 15, 20, 25, 30, 45, 60 and 90 |
2024/02/05 |
| Elbasvir/Grazoprevir |
Tablet |
I (Basket) |
100 |
Phosphate Buffer, pH 6.8 with 0.45% (w/v) Polysorbate 80 |
900 |
10, 15, 20, 30, 45 and 60 |
2016/07/28 |
| Eletriptan Hydrobromide |
Tablet |
I (Basket) |
100 |
0.1 N HCl |
900 |
5, 10, 15 and 30 |
2009/04/02 |
| Elexacaftor, Ivacaftor, Tezacaftor [FDC:ELE+ IVA+ TEZ]; Ivacaftor [IVA] |
Tablet/Tablet (Copackage) |
II (Paddle) |
FDC: ELE: 75/IVA: 65/TEZ:75; IVA: 75 |
FDA: ELE: 1.8% (v/v) Polysorbate 20 in 50 mM sodium phosphate, pH 6.8/ IVA: 0.4% (w/v) SLS in 50 mM sodium phosphate, pH 6.8/TEZ: 0.2% (w/v) SLS solution in 0.1N HCl; IVA: 1.8% (v/v) Polysorbate 20 in 50 mM sodium phosphate, pH 6.8 |
FDC: ELE: 900/IVA: 900/TEZ:900; IVA 900 |
5, 10, 15, 20 and 30 |
2021/08/19 |
| Eliglustat Tartrate |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Eltrombopag Olamine |
Tablet |
II (Paddle) |
50 |
0.5% Polysorbate 80 in Phosphate Buffer, pH 6.8 |
900 |
10, 15, 20, 30, 45, and 60 |
2012/06/07 |
| Eltrombopag Olamine |
Suspension |
II (Paddle) |
50 |
50 mM potassium phosphate in water, pH 6.8 with 0.2% polysorbate 80 |
750 |
4, 8, 12, 15 and 20 |
2016/10/20 |
| Eluxadoline |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Elvitegravir |
Tablet |
II (Paddle) with sinker |
75 |
2.0% w/v Polysorbate 80 in 0.01 N HCl
(pH 2.0) at 37 ºC |
700 mL for 85 mg tablets; 1000 mL for 150 mg tablets
1000 mL for 150 mg tablets |
10, 20, 30, 45 and 60 |
2015/12/24 |
| Empagliflozin |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Empagliflozin/ Metformin HCl |
Tablet (Extended Release) |
I (Basket) |
100 |
Phosphate Buffer, pH 6.8 |
900 |
Metformin: 1, 2, 4, 6, 8, 10 and 12 hours: Empagliflozin: 10, 15, 20, 30, 45 and 60 minutes; |
2017/01/19 |
| Empagliflozin/Linagliptin |
Tablet |
II (Paddle) |
50 |
pH 6.8 Phosphate Buffer |
900 |
10, 15, 20, 30 and 45 |
2015/12/24 |
| Empagliflozin/Linagliptin/Metformin HCl |
Tablet (Extended Release) |
I (Basket) |
100 |
Phosphate Buffer, pH 6.8 |
900 |
Metformin: 1, 2, 4, 6, 8, 10 and 12 hours: Empagliflozin and Linagliptin: 10, 15, 20, 30, 45 and 60 minutes |
2020/04/02 |
| Empagliflozin/Metformin HCl |
Tablet |
II (Paddle) |
50 |
Phosphate Buffer, pH 6.8 (degas) |
900 |
5, 10, 15, 20 and 30 |
2016/06/30 |
| Emtricitabine |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Emtricitabine/Rilpivirine HCl/Tenofovir Alafenamide Fumarate |
Tablet |
II (Paddle |
75 |
Rilpivirine (RPV): 0.5% Polysorbate 20 in 0.01 N HCl; Emtricitabine (ETC) and Tenofovir alafenamide (TAF): 50 mM Sodium Citrate, pH 5.5, |
RPV: 1000 mL; ETC and TAF: 500 mL |
5, 10, 15, 20, 30 and 45 |
2016/07/28 |
| Emtricitabine/Rilpivirine HCl/Tenofovir Disoproxil Fumarate |
Tablet |
II (Paddle) with sinker |
75 |
0.5%(w/w) polysorbate 20 in 0.01N HCl (pH 2.0) |
1000 |
Emtricitabine and Tenofovir: 5, 10, 15, 20 and 30; Rilpivirine: 10, 20, 30, 45, 60, 75, 90 and 120 |
2015/01/15 |
| Emtricitabine/Tenofovir Alafenamide Fumarate |
Tablet |
II (Paddle |
75 |
50 mM Sodium Citrate buffer, pH 5.5 |
500 |
5, 10, 15, 20, 30 and 45 |
2016/07/28 |
| Emtricitabine/Tenofovir Disoproxil Fumarate |
Tablet |
II (Paddle) |
50 |
0.01 N HCl |
900 |
5, 10, 15, 30 and 45 |
2007/01/03 |
| Enalapril Maleate |
Tablet |
|
|
Refer to USP |
|
|
2008/09/03 |
| Entacapone |
Tablet |
II (Paddle) |
50 |
Phosphate Buffer, pH 5.5 |
900 |
10, 20, 30 and 45 |
2004/01/29 |
| Entecavir |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Entrectinib |
Capsule |
II (Paddle) with Sinker |
75 |
50 mM Potassium Phosphate, pH 6.0 with 0.374% w/v polysorbate 80 |
1000 |
15, 20, 30, 45, 60 and 75 |
2021/08/19 |
| Enzalutamide |
Tablet |
II (Paddle) |
50 |
Phosphate Buffer, pH 7.5 |
900 |
5, 10, 15, 20, 30 and 45 |
2022/05/12 |
| Enzalutamide |
Capsule |
II (Paddle) with sinker |
50 |
Tier 1 Medium: 0.3%
cetyl trimethyl ammonium bromide (CTAB) in 0.1
N HCl;Tier 2 Medium: 0.3% CTAB in 0.1
N HCl containing Pepsin 600,000 USP units/L. |
900 |
10, 15, 20, 30 and 45 |
2015/05/28 |
| Eplerenone |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Eprosartan Mesylate |
Tablet |
II (Paddle) |
75 |
0.2 M Phosphate Buffer, pH 7.5 |
1000 |
15, 30, 45 and 60 |
2008/07/14 |
| Eprosartan Mesylate/Hydrochlorothiazide |
Tablet |
II (Paddle) |
75 |
0.2 M Phosphate Buffer, pH 7.5 |
1000 |
10, 20, 30 and 45 |
2008/02/19 |
| Ergocalciferol |
Capsule |
II (Paddle) |
100 |
0.5 N NaOH with 10% Triton-X-100 |
500 |
15, 30, 45, 60 and 90 |
2010/08/05 |
| Erlotinib HCl |
Tablet |
II (Paddle) |
75 |
0.02% Tween 80 in 0.01 N HCl |
1000 |
5, 10, 15, 20, 30 and 45 |
2018/10/18 |
| Erythromycin |
Tablet |
|
|
Refer to USP |
|
|
2015/12/24 |
| Erythromycin |
Tablet (Delayed Release) |
|
|
Refer to USP |
|
|
2013/10/31 |
| Erythromycin Ethylsuccinate |
Suspension |
II (Paddle) |
75 |
Monobasic Sodium Phosphate, pH 6.8 Buffer with 1% SLS
Buffer w/ 1% SLS |
900 |
10, 20, 30, 45 and 60 |
2004/01/27 |
| Erythromycin Ethylsuccinate |
Oral granule |
|
|
Develop a dissolution method |
|
|
2016/06/30 |
| Erythromycin Ethylsuccinate |
Tablet |
|
|
Refer to USP |
|
|
2021/04/22 |
| Erythromycin Ethylsuccinate/Sulfisoxazole Acetyl |
Granules for Oral Suspension |
|
|
Develop a dissolution method |
|
|
2010/09/02 |
| Escitalopram Oxalate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Escitalopram Oxalate |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Eslicarbazepine Acetate |
Tablet |
II (Paddle) |
100 |
Acetate Buffer, pH 4.5 |
1000 |
5, 10, 15, 20, 30 and 45 |
2015/08/27 |
| Esomeprazole Magnesium |
Capsule (Delayed Release Pellets) |
|
|
Refer to USP |
|
|
2015/08/27 |
| Esomeprazole Magnesium |
Tablet (Delayed Release) |
II (Paddle) |
100 |
Acid stage: 0.1 N HCl; Buffer stage: Phosphate Buffer, pH 6.8 |
Acid stage: 300; Buffer stage: 1000 |
Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60 |
2016/10/20 |
| Esomeprazole Magnesium |
For Oral Suspension (Delayed Release) |
II (Paddle |
100 |
Acid stage: 0.1 N HCl; Buffer stage: Sodium Phosphate Buffer, pH 6.8 |
Acid stage: 300; Buffer stage: 1000 |
Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60 |
2010/09/02 |
| Esomeprazole Magnesium |
Tablet (Orally Disintegrating, Delayed Release) |
II (Paddle) |
Acid stage: 100; Buffer stage: 75 |
Acid stage: 0.1 N HCl; Buffer stage: Phosphate Buffer, pH 6.8 |
Acid stage: 300; Buffer stage: 1000 |
Acid stage: 120; Buffer stage: 5, 10, 20, 30 and 45 |
2021/04/22 |
| Estazolam |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Esterified Estrogens |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Estradiol |
Vaginal Ring |
Incubator shaker |
130 |
0.9% Saline |
250 |
1, 9, 16, 17, 18, 19, 45 days |
2007/01/03 |
| Estradiol |
Vaginal Insert |
III (Reciprocating Cylinder) |
30 dips/min |
0.1 N HCl with 0.5% SLS |
250 |
30, 60, 90 and 120 |
2024/11/01 |
| Estradiol |
Vaginal Tablet |
I (Basket) |
40 |
Phosphate Buffer, pH 4.75 ± 0.05 |
500 |
1, 2, 3, 5, 8, 10 and 12 hours |
2009/07/21 |
| Estradiol (0.014 mg/24 hr) |
Film, Transdermal (Extended Release) |
|
|
Develop a method to characterize in vitro release |
|
|
2010/10/28 |
| Estradiol (0.025 mg/24 hr, 0.0375 mg/24 hr, 0.05 mg/24 hr, 0.06 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr) |
Film, Transdermal (Extended Release) |
|
|
Develop a method to characterize in vitro release |
|
|
2010/10/28 |
| Estradiol (Test 1) (0.025 mg/24 hr, 0.0375 mg/24 hr, 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr) |
Film, Transdermal (Extended Release) |
VI (Cylinder) attach the patch to a disk at the bottom of the cylinder |
50 |
Water at 32 ± 0.5°C |
0.025 mg/24 hr and 0.0375 mg/24 hr: 500 mL; 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr: 900 mL |
1, 2, 4, 6, 8, 10 and 12 hours |
2010/10/28 |
| Estradiol (Test 2) (0.05 mg/24 hr and 0.1 mg/24 hr) |
Film, Transdermal (Extended Release) |
V (Paddle over Disk) with a stainless steel disk |
50 |
Water at 32 ± 0.5°C |
900 |
6, 12, 18, 24, 36, 48, 60, 72 and 96 hours |
2010/10/28 |
| Estradiol (Test 3) 0.0375 mg/24 hr, 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr) |
Film, Transdermal (Extended Release) |
VI (Cylinder) attach the patch to the cylinder with double-sided tape |
50 |
Water at 32 ± 0.5°C |
0.0375 mg/24 hr: 500 mL; 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr: 900 mL |
1, 2, 4, 6, 10, 12, 18, 24 and 36 hours |
2013/10/31 |
| Estradiol/Levonorgestrel |
Film, Transdermal (Extended Release) |
V (Paddle over Disk) attach the patch to the stainless steel plate with double-sided tape |
50 |
30% Ethanol in water at 32±0.5°C |
660 |
30, 60, 120, 180, 240 and 300 |
2023/03/30 |
| Estradiol/Norethindrone Acetate |
Film, Transdermal (Extended Release) |
V (Paddle over Disk) |
50 |
0.24% SDS in water at 32±0.5°C |
0.05 mg/0.14 mg/24 hr: 500; 0.05mg/0.25 mg/24 hr: 900 |
1, 2, 4, 8, 12 and 14 hours |
2023/03/30 |
| Estradiol/Norethindrone Acetate |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Estradiol/Norgestimate (1mg/0.09mg) |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Estradiol/Progesterone |
Capsule |
III (Reciprocating Cylinder) [40 mesh for bottom and top of the inner tube] |
|
3% sodium lauryl sulfate (SLS) in 0.1N HCl |
250 |
10, 20, 30, 45 and 60 |
2020/01/30 |
| Estramustine Phosphate Sodium |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Estrogens Conjugated Synthetic A |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Estrogens, Conjugated (EC)/Medroxyprogesterone Acetate (MPA) |
Tablet |
II (Paddle) with sinker |
50 |
EC: 0.02 M Na Acetate Buffer (pH 4.5); MPA: Develop a dissolution method |
900 |
|
2023/09/15 |
| Estrogens, Conjugated Synthetic B |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Eszopiclone |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Ethacrynic Acid |
Tablet |
|
|
Refer to USP |
|
|
2010/12/23 |
| Ethambutol HCl |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Ethinyl Estradiol |
Tablet |
|
|
Refer to USP |
|
|
2011/09/22 |
| Ethinyl Estradiol/Ethynodiol Diacetate |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Ethinyl Estradiol/Etonogestrel |
Vaginal Ring |
|
|
Develop a method to characterize in vitro release |
|
|
2013/01/31 |
| Ethinyl Estradiol/Levonorgestrel |
Transdermal System |
V (paddle over disk) |
75 |
0.25% Hydroxypropyl-Beta-Cyclodextrin (HPCD) in Water (Deaerated ), 32±0.5˚C |
500 |
1, 2, 4, 6, 12, 24, 36, 48, 72 and 96 hours |
2022/05/12 |
| Ethinyl Estradiol/Levonorgestrel |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Ethinyl Estradiol/Norethindrone |
Tablet (Chewable) |
II (Paddle) |
75 |
0.09% Sodium Lauryl Sulfate in 0.1 N HCl |
500 |
10, 15, 20, 30 and 45 |
2008/01/14 |
| Ethinyl Estradiol/Norethindrone |
Tablet |
|
|
Refer to USP |
|
|
2009/07/15 |
| Ethinyl Estradiol/Norethindrone Acetate |
Tablet |
|
|
Refer to USP |
|
|
2009/07/15 |
| Ethinyl Estradiol/Norethindrone Acetate |
Capsule |
II (Paddle) |
100 |
Phosphate Buffer, pH 6.8, containing 0.07% w/v Triton X 100 |
900 |
5, 10, 20, 30, 45, 60 and 75 |
2018/02/15 |
| Ethinyl Estradiol/Norethindrone Acetate [0.01mg,0.01 mg;1 mg] |
Tablet (Chewable) |
II (Paddle) |
75 |
0.025 M Na Acetate Buffer with 0.15% Sodium Lauryl Sulfate [SLS] (pH 5.0) [degassed] |
500 |
10, 15, 20, 30 and 45 |
2015/12/24 |
| Ethinyl Estradiol/Norethindrone Acetate [0.02mg;1mg] |
Tablet (Chewable) |
II (Paddle) |
75 |
0.025 M Sodium Acetate Buffer with 0.15% SLS, pH 5.0 |
600 |
10, 15, 20, 30 and 45 |
2014/02/14 |
| Ethinyl Estradiol/Norgestimate |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Ethinyl Estradiol/Norgestimate (AB) |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Ethinyl Estradiol/Norgestrel |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Ethinyl Estradiol; Norelgestromin |
Film, Transdermal |
Modified USP Type V (Paddle-over-disk) |
50 |
0.1% Hydroxypropyl-beta-cyclodextrin at 32º C |
900 |
0.25, 0.5, 1, 2, 4, 8, 12, 16, 20 and 24 hours |
2009/05/20 |
| Ethionamide |
Tablet |
I (Basket) |
75 |
0.1 N HCl |
900 |
10, 20, 30, 45 and 60 |
2013/01/31 |
| Ethosuximide |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Etidronate Disodium |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Etodolac |
Tablet |
|
|
Refer to USP |
|
|
2008/01/14 |
| Etodolac |
Tablet (Extended Release) |
|
|
Refer to USP |
|
|
2010/06/24 |
| Etoposide |
Capsule |
|
|
Refer to USP |
|
|
2010/06/24 |
| Etrasimod Argenine |
Tablet |
II (Paddle) |
75 |
50 mM Phosphate buffer w/0.2% Tween 20, pH 6.8 |
900 |
5, 15, 20, 30 and 45 |
2024/11/15 |
| Etravirine (200 mg) |
Tablet |
II (Paddle) |
70 |
1.0 % Sodium lauryl sulfate (SLS) in 0.01 M HCl in two phases: Phase 1: 1000 mL of degassed 0.01 M HCl for 10 minutes. Phase 2: Add 800 mL of 2.25% SLS in 0.01 M HCl. |
1000 (phase 1): 1800 (phase 2) |
Phase 1: No Sampling. Phase 2: 5, 10, 20, 30, 45, 60 and 90 |
2011/06/30 |
| Etravirine (25 and 100 mg) |
Tablet |
II (Paddle) |
50 |
1.0 % Sodium lauryl sulfate (SLS) in 0.01 M HCl in two phases: Phase 1: 500 mL of degassed 0.01 M HCl for 10 minutes. Phase 2: Add 400 mL of 2.25% SLS in 0.01 M HCl. |
500 (phase 1): 900 (phase 2) |
Phase 1: No Sampling. Phase 2: 5, 10, 20, 30, 45, 60 and 90 |
2014/08/14 |
| Everolimus |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Exemestane |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Exenatide Synthetic (2 mg) |
For Suspension, Extended Release |
|
|
Develop a method to characterize in vitro release |
|
|
2022/07/07 |
| Exenatide Synthetic (2 mg/0.85 mL) |
Suspension, Extended Release |
|
|
Develop a method to characterize in vitro release |
|
|
2022/07/07 |
| Ezetimibe |
Tablet |
II (Paddle) |
50 |
0.45% SLS in 0.05 M Acetate Buffer, pH 4.5 |
500 |
10, 20, 30 and 45 |
2008/01/14 |
| Ezetimibe/Simvastatin |
Tablet |
II (Paddle) |
50 |
0.01 M Sodium Phosphate, pH 7.0/0.5% SDS |
900 |
5, 10, 20 and 30 |
2007/01/03 |
| Ezogabine |
Tablet |
II (Paddle) |
75 |
0.01 N HCl |
1000 |
5, 10, 15, 20 and 30 |
2013/08/15 |
| Famciclovir |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Famotidine |
Tablet (Orally Disintegrating) |
II (Paddle) |
50 |
0.1 M Phosphate Buffer, pH 4.5 |
900 |
2, 5, 10, 15 and 20 |
2008/10/06 |
| Famotidine |
Tablet (Chewable) |
II (Paddle) |
50 |
0.1 M Phosphate Buffer, pH 4.5 |
900 |
10, 20, 30, 45 and 60 |
2004/01/29 |
| Famotidine |
Tablet |
|
|
Refer to USP |
|
|
2023/02/09 |
| Famotidine |
Suspension |
II (Paddle) |
25 and 50 |
0.1 M Phosphate buffer, pH 4.5 |
900 |
10, 15, 30 and 45 |
2008/11/25 |
| Famotidine/Calcium Carbonate/Magnesium Hydroxide |
Tablet (Chewable) |
|
|
Develop a dissolution method |
|
|
2009/12/15 |
| Famotidine/Ibuprofen |
Tablet |
II (Paddle) |
50 |
0.05 M Phosphate Buffer, pH 7.2 |
900 |
5, 10, 15, 20, 30 and 45 |
2013/08/15 |
| Febuxostat |
Tablet |
II (Paddle) |
75 |
0.05 M Phosphate Buffer, pH 6.0 |
900 |
5, 10, 15, 20 and 30 |
2013/08/15 |
| Fedratinib HCl |
Capsule |
I (Basket) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20 and 30 |
2021/08/19 |
| Felbamate |
Suspension |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Felbamate |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Felodipine |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Fenofibrate |
Capsule |
II (Paddle) |
75 |
Phosphate Buffer w/ 2% Tween 80 and 0.1% pancreatin, pH 6.8 |
900 |
15, 30, 45, 60, 90 and 120 |
2008/02/19 |
| Fenofibrate |
Capsule (Micronized) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Fenofibrate (40 mg and 120 mg) |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Fenofibrate (48 mg and 145 mg) |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Fenofibrate (54 mg and 160 mg) |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Fenofibric Acid |
Tablet |
II (Paddle) |
75 |
Phosphate buffer, pH 6.8 |
900 |
5, 15, 30, 45 and 60 |
2010/08/05 |
| Fenoprofen Calcium |
Capsule |
|
|
Refer to USP |
|
|
2008/11/25 |
| Fentanyl |
Transdermal |
VII (Reciprocating holder)- cylinder. |
30 cycles per minute. amplitude of
about 2m. |
Equimolar mixture of 0.005 M phosphoric acid solution, and 0.005 M sodium phosphate, monobasic monohydrate (pH ~ 2.6). at 32° C. Change the test samples into fresh pre-equilibrated release medium at the time points indicated. Remove the protective liner and place the film onto a piece of nylon netting with
adhesive facing the net. Secure the netting and transdermal system using
nylon tie wraps at the top and bottom of the cylinder on the holder. The adhesive side faces towards the media. |
250 mL for the 75 and 100 mcg/hr, 200 mL for the 50 mcg/hr and 150 mL for the 25 and 12.5 mcg/hr dosage strength. |
0.5, 1, 2, 4 and 24 hours |
2011/06/09 |
| Fentanyl Citrate |
Tablet (Sublingual) |
II (Paddle) |
50 |
Phosphate Buffer, pH 6.8 |
500 |
1, 3, 5, 7, 10, 15 and 20 |
2013/08/15 |
| Fentanyl Citrate |
Lozenges |
II (Paddle) |
175 |
0.1 M Phosphate Buffer, pH 4.5 |
500 |
5, 10, 20, 30 and 40 |
2009/05/20 |
| Fentanyl Citrate (0.1 mg and 0.4 mg) |
Tablet (Buccal) |
II (Paddle) small volume dissolution apparatus |
100 |
Phosphate Buffered Saline solution, pH 7.0 |
100 |
3, 5, 7.5, 10, 15 and 20 |
2009/11/20 |
| Fentanyl Citrate (0.2 mg, 0.3 mg, 0.6 mg and
0.8 mg) |
Tablet (Buccal) |
II (Paddle) small volume dissolution apparatus |
100 |
Phosphate Buffered Saline solution, pH 7.0 |
200 |
3, 5, 7.5, 10, 15 and 20 |
2009/11/20 |
| Fentanyl Citrate (0.2 mg, 0.4 mg, 0.6 mg and
0.8 mg) |
Film (Buccal) |
I (Basket) 100 mL dissolution vessel |
100 |
25-mM Phosphate Buffer, pH 6.4 |
60 |
5, 10, 15, 20, 30 and 45 |
2009/12/15 |
| Fentanyl Citrate (1.2 mg) |
Film (Buccal) |
I (Basket) 100 mL dissolution vessel |
100 |
25-mM Phosphate Buffer, pH 6.4 |
100 |
5, 10, 15, 20, 30 and 45 |
2009/12/15 |
| Ferric Citrate |
Tablet |
II (Paddle) |
100 |
EDTA media ( 2.0 grams of EDTA Na2 2H2O to 1000 mL of purified water) |
900 |
10, 20, 30, 45 and 60 |
2015/08/27 |
| Ferric Maltol |
Capsule |
II (Paddle with sinker) |
75 |
Tier 1: KCl/HCl Buffer, pH 1.2; Tier 2: KCl/HCl Buffer pH 1.2, with pepsin |
1000 |
5, 10, 20, 30 and 45 |
2020/01/30 |
| Ferrous Fumarate |
Tablet |
|
|
Refer to USP |
|
|
2016/03/17 |
| Fesoterodine Fumarate |
Tablet (Extended Release) |
II (Paddle) with sinker |
75 |
Phosphate Buffer, pH 6.8 |
900 |
1, 2, 4, 6, 8, 10, 12, 16 and 20 hours |
2013/08/15 |
| Fexinidazole |
Tablet |
II (Paddle) |
75 |
0.1 N HCl with 3% w/v SLS |
2000 |
10, 20, 30, 40, 50 and 60 |
2023/05/18 |
| Fexofenadine HCl |
Tablet |
II (Paddle) |
50 |
0.001 N HCl |
900 |
5, 10, 20, 30 and 45 |
2004/02/19 |
| Fexofenadine HCl |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Fexofenadine HCl |
Suspension |
II (Paddle) |
50 |
0.001 N HCl |
900 |
10, 20, 30 and 45 |
2008/11/25 |
| Fexofenadine HCl |
Tablet (Orally Disintegrating) |
II (Paddle) |
50 |
0.001 N HCl |
500 |
5, 10, 15, 30 and 45 |
2008/09/03 |
| Fexofenadine HCl/Pseudoephedrine HCl |
Tablet (Extended Release) |
|
|
Refer to USP |
|
|
2009/04/02 |
| Fezolinetant |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2024/08/05 |
| Fidaxomicin |
For Oral Suspension |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Fidaxomicin |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Finafloxacin |
Otic Suspension |
|
|
Develop a method to characterize in vitro release |
|
|
2016/03/17 |
| Finasteride |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Finasteride; Tadalafil |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/02/05 |
| Finerenone |
Tablet |
II (Paddle) |
75 |
Acetate Buffer, pH 4.5 (for 10 mg strength) and Acetate Buffer, pH 4.5 with 0.1% polysorbate 20 (for 20 mg strength) |
900 |
5, 10, 15, 20 and 30 |
2023/02/09 |
| Fingolimod |
Capsule |
I (Basket) |
100 |
0.1 N HCl with 0.2% SDS (sodium dodecyl sulfate) |
500 |
5, 10, 15, 20 and 30 |
2013/08/15 |
| Fingolimod Lauryl Sulfate |
Tablet, Orally Disintegrating |
II (Paddle) with sinker |
50 |
0.1 N HCl with 0.2% sodium dodecyl sulfate (SDS) |
500 |
5, 10, 15, 20, 25, 30 and 45 |
2023/11/30 |
| Flavoxate HCl |
Tablet |
I (Basket) |
100 |
0.1 N HCl |
900 |
5, 10, 20 and 30 |
2004/01/29 |
| Flecainide Acetate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Flibanserin |
Tablet |
II (Paddle) |
50 |
Mcilvaine Buffer (Citric Acid/Phosphate Buffer), pH 4.0 |
900 |
5, 10, 15, 20 and 30 |
2016/06/30 |
| Fluconazole |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Fluconazole (200 mg/5 mL) |
Suspension |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Fluconazole (50 mg/5 mL) |
Suspension |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Flucytosine |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Fludarabine Phosphate |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Fludrocortisone Acetate |
Tablet |
|
|
Refer to USP |
|
|
2009/05/20 |
| Fluoxetine |
Capsules (Delayed Release) |
|
|
Refer to USP |
|
|
2007/07/25 |
| Fluoxetine HCl |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Fluoxetine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Fluoxetine/Olanzapine |
Capsule |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 20, 30 and 45 |
2006/08/17 |
| Fluphenazine HCl |
Tablet |
|
|
Refer to USP |
|
|
2017/11/02 |
| Flutamide |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Fluvastatin Sodium |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Fluvastatin Sodium |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Fluvoxamine Maleate |
Capsule (Extended Release) |
II (Paddle) |
50 |
Phosphate Buffer, pH 6.8 |
900 |
1, 2, 4, 6, 8 and 12 hours |
2010/01/15 |
| Fluvoxamine Maleate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Fosamprenavir Calcium |
Tablet |
II (Paddle) |
75 |
250 mM Sodium Acetate/Acetic acid buffer pH 3.5 |
900 |
10, 20, 30 and 45 |
2005/12/16 |
| Fosamprenavir Calcium |
Oral Suspension |
II (Paddle) |
25 |
10 mM HCl |
900 |
5, 10,15 and 20 |
2007/12/03 |
| Fosfomycin Tromethamine |
For Suspension |
|
|
Develop a dissolution method |
|
|
2017/07/20 |
| Fosinopril Sodium |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Fosinopril Sodium/Hydrochlorothiazide |
Tablet |
|
|
Refer to USP |
|
|
2008/08/11 |
| Fostemsavir Tromethamine |
Tablet (Extended Release |
I
(Basket) |
100 |
0.05 M Phosphate Buffer, pH 6.8
buffer, pH 6.8 |
1000 |
1, 2, 3, 5, 7, 10, 12, 16, 20 and 24 hours |
2021/08/19 |
| Frovatriptan succinate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Furosemide |
Tablet |
|
|
Refer to USP |
|
|
2010/08/05 |
| Futibatinib |
Tablet |
II (Paddle) |
50 |
50 mM phosphate dihydrogen phosphate buffer, pH 6.8 with 0.5% Tween 80 |
900 |
5, 10, 15, 30, 45, 60 and 75 |
2023/11/30 |
| Gabapentin |
Tablet |
I (Basket) |
100 |
Modified simulated gastric fluid (SGF) |
900 |
1, 2, 4, 6, 8, 10, 12, 14 and 16 hours |
2023/11/30 |
| Gabapentin |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Gabapentin |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Gabapentin Enacarbil |
Tablet (Extended Release) |
II (Paddle) |
50 |
10 mM Phosphate buffer at pH 7.4 with 1.0 % SLS |
500 (for 300 mg); 900 (for 600 mg) |
0.5, 1, 2, 4, 6, 8, 12 and 24 hours |
2013/01/31 |
| Galantamine HBr |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Galantamine HBr |
Capsule (Extended Release) |
II (Paddle) |
50 |
50 mM potassium dihydrogen phosphate buffer pH 6.5 |
900 |
1, 4, 10 and 12 hours |
2006/01/20 |
| Ganaxolone |
Suspension |
II (Paddle) |
25 |
2.8% SDS |
900 |
2.5, 5, 7.5, 10, 15, 20 and 30 |
2023/11/30 |
| Ganciclovir |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Gefitinib |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Gemfibrozil |
Tablet |
|
|
Refer to USP |
|
|
2007/07/25 |
| Gemifloxacin Mesylate |
Tablet |
II (Paddle) |
50 |
0.01 N HCl |
900 |
10, 20, 30 and 45 |
2007/01/03 |
| Gilteritinib Fumarate |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 15, 20, 30 and 45 |
2020/08/27 |
| Glimepiride |
Tablet |
II (Paddle) |
75 |
Phosphate Buffer, pH 7.8 |
900 |
5, 10, 15 and 30 |
2004/07/23 |
| Glimepiride/Pioglitazone HCl |
Tablet |
II (Paddle) |
75 |
For Pioglitazone: pH 2.0, HCl Buffer. For Glimepiride: pH 6.8, Sodium Phosphate Buffer with 0.2% sodium dodecyl sulfate |
900 |
For Pioglitazone: 10, 15, 20, 30 and 45; For Glimepiride: 10, 15, 20 and 30 |
2009/04/02 |
| Glimepiride/Rosiglitazone Maleate |
Tablet |
II (Paddle) |
75 |
0.01 M HCl with 0.5% Sodium Dodecyl Sulfate |
900 |
5, 10, 15, 30, 45 and 60 |
2007/01/03 |
| Glipizide |
Tablet (Extended Release) |
II (Paddle) |
50 |
Simulated Intestinal Fluid without pancreatin, pH 7.5 |
900 |
1, 2, 4, 8, 16 hours and until at least 80% dissolved |
2008/04/10 |
| Glipizide |
Tablet |
|
|
Refer to USP |
|
|
2010/08/05 |
| Glipizide/Metformin HCL |
Tablet |
|
|
Refer to USP |
|
|
2008/12/18 |
| Glyburide (Micronized) |
Tablet |
II (Paddle) |
50 |
0.05 M Phosphate Buffer, pH 7.5 |
900 |
10, 20, 30, 45 and 60 |
2004/02/02 |
| Glyburide (Non-micronized) |
Tablet |
II (Paddle) |
75 |
0.05 M Borate Buffer, pH 9.5 |
500 |
10, 20, 30, 45 and 60 |
2004/02/02 |
| Glyburide/Metformin HCl |
Tablet |
|
|
Refer to USP |
|
|
2008/01/14 |
| Glycopyrrolate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Goserelin Acetate |
Implant |
Prior to sampling, the jar is removed from incubation and mechanically swirled with digital orbital shaker |
Swirl orbit of 50 mm at 205 rpm for 6 seconds |
Each implant should be incubated in 50 mL of phosphate buffered saline, pH 7.4, at 39°C (warmed overnight before the implants are added), in a 120-mL Wheaton jar. |
50 |
3, 14, 35, 56 and 84 days (10.8 mg strength); 7, 14, 17, 21 and 28 days (3.6 mg strength) |
2008/11/04 |
| Granisetron |
Film, Transdermal (Extended Release) |
VI (Cylinder) |
50 |
80 microL /L phosphoric acid (85%) at 32 ± 0.5°C |
1000 |
2, 6, 12, 24, 36, 48, 60, 72 and 96 hours |
2011/03/03 |
| Granisetron |
Injectable (Extended Release) |
|
|
Develop a method to characterize in vitro release |
|
|
2016/12/22 |
| Granisetron HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Griseofulvin |
Oral Suspension |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Griseofulvin (Microcrystalline) |
Oral Suspension |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Griseofulvin (Microcrystalline) |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Griseofulvin (Ultramicrocrystalline) |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Guaifenesin |
Tablet (Extended Release) |
I (Basket) |
75 |
0.1 N HCl |
900 |
1, 2, 4, 6 and 12 hours |
2007/01/03 |
| Guaifenesin/Pseudoephedrine Hydrochloride |
Tablet (Extended Release) |
I (Basket) |
50 |
0.01 N HCl |
900 |
1, 2, 6, and 12 hours |
2008/11/25 |
| Guanfacine |
Tablet (Extended Release) |
II (Paddle) |
75 |
HCl Buffer, pH 2.2 |
900 |
1, 2, 4, 6, 8, 10, 12, 16, 20 and 24 hours |
2010/07/01 |
| Guanfacine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
500 |
|
2021/08/19 |
| Haloperidol |
Tablet |
|
|
Refer to USP |
|
|
2008/11/25 |
| Homatropine Methylbromide/Hydrocodone Bitartrate |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Hydralazine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Hydrochlorothiazide |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Hydrochlorothiazide |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Hydrochlorothiazide/Irbesartan |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
1000 |
10, 20, 30 and 45 |
2008/09/24 |
| Hydrochlorothiazide/Lisinopril |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 20, 30, 45 and 60 |
2004/02/03 |
| Hydrochlorothiazide/Losartan Potassium |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Hydrochlorothiazide/Metoprolol Succinate |
Tablet (Extended Release) |
II (Paddle) |
Hydrochlorothiazide: 100; Metoprolol succinate: 75 |
Hydrochlorothiazide: 0.1N HCl; Metoprolol succinate: Phosphate Buffer, pH 6.8 |
Hydrochlorothiazide: 500; Metoprolol succinate: 500 |
Hydrochlorothiazide: 10, 15, 20, 30, and 45 minutes; Metoprolol succinate: 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours |
2013/10/31 |
| Hydrochlorothiazide/Metoprolol Tartrate |
Tablet |
|
|
Refer to USP |
|
|
2012/01/05 |
| Hydrochlorothiazide/Moexipril HCl |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15 and 30 |
2004/02/10 |
| Hydrochlorothiazide/Olmesartan Medoxomil |
Tablet |
II (Paddle) |
50 |
0.05 M Phosphate Buffer, pH 6.8 |
900 |
5, 10, 15, 20, 30, 45 and 60 |
2007/07/09 |
| Hydrochlorothiazide/Quinapril HCl |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Hydrochlorothiazide/Spironolactone |
Tablet |
|
|
Refer to USP |
|
|
2009/08/27 |
| Hydrochlorothiazide/Telmisartan |
Tablet |
|
|
Refer to USP |
|
|
2016/06/30 |
| Hydrochlorothiazide/Triamterene |
Tablet |
|
|
Refer to USP |
|
|
2013/07/31 |
| Hydrochlorothiazide/Valsartan |
Tablet |
|
|
Refer to USP |
|
|
2016/07/28 |
| Hydrochlorothizide/Triamterene |
Capsule |
|
|
Refer to USP |
|
|
2008/10/06 |
| Hydrocodone Bitartrate |
Capsule (Extended Release) |
I (Basket) |
100 |
0.05 M Phosphate Buffer, pH 6.8 |
500 |
1, 2, 4, 6, 8, 10 and 12 hours |
2015/05/28 |
| Hydrocodone Bitartrate |
Tablet (Extended Release) |
I (Basket-10 mesh) |
100 |
Simulated gastric fluid (SGF) without enzyme (pH 1.2) |
900 |
1, 2, 4, 8, 12, 16, 20 and 24 hours |
2016/04/14 |
| Hydrocodone Bitartrate/Ibuprofen |
Tablet |
II (Paddle) |
50 |
Phosphate Buffer, pH 7.2 |
900 |
5, 10, 15 and 30 |
2004/02/04 |
| Hydrocortisone |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Hydromorphone HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Hydromorphone HCl |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Hydroxychloroquine Sulfate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/04/16 |
| Hydroxyurea |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2022/07/07 |
| Hydroxyurea |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Hydroxyzine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Hydroxyzine Pamoate |
Capsule |
|
|
Refer to USP |
|
|
2009/04/02 |
| Hydroxyzine Pamoate |
Suspension |
|
|
Develop a dissolution method |
|
|
2009/04/02 |
| Ibandronate Sodium |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Ibrexafungerp Citrate |
Tablet |
II (Paddle) |
50 |
0.1N HCl |
900 |
10, 15, 20, 30 and 45 |
2023/02/09 |
| Ibrutinib |
Capsule |
II (Paddle) |
75 |
3.0% w/v Polysorbate 20 in 50 mM Phosphate Buffer, pH 6.8 |
900 |
5, 10, 20, 30 and 45 |
2015/06/25 |
| Ibrutinib (140 and 280 mg) |
Tablet |
II (Paddle) |
75 |
3.0% w/v Polysorbate 20 in 50 mM Phosphate Buffer, pH 6.8 |
900 |
10, 20, 30, 45 and 60 |
2020/04/02 |
| Ibrutinib (420 and 560 mg) |
Tablet |
II (Paddle) |
75 |
6.0% w/v Polysorbate 20 in 50 mM Phosphate Buffer, pH 6.8 |
900 |
10, 20, 30, 45 and 60 |
2020/04/02 |
| Ibuprofen |
Capsule (Soft-Gelatin/Liquid Fill) |
I (Basket) |
150 |
50mM Phosphate Buffer, pH 7.2 |
900 |
5, 10, 20, 30 and 45 |
2013/05/09 |
| Ibuprofen |
Tablet (Chewable) |
II (Paddle) |
50 |
0.05 M Phosphate Buffer, pH 7.2 |
900 |
10, 20, 30 and 45 |
2004/02/04 |
| Ibuprofen |
Suspension |
|
|
Refer to USP |
|
|
2008/11/04 |
| Ibuprofen |
Suspension/Drop |
II (Paddle) |
50 |
Phosphate Buffer, pH 7.2 |
900 |
5, 10, 15 and 20 |
2008/11/04 |
| Ibuprofen |
Tablet |
|
|
Refer to USP |
|
|
2007/07/25 |
| Ibuprofen Potassium |
Capsule (Soft-Gelatin/Liquid Fill) |
I (Basket) |
150 |
Phosphate Buffer, pH 7.2 |
900 |
5, 10, 20 and 30 |
2004/02/04 |
| Ibuprofen Sodium |
Capsule |
I (Basket) |
150 |
Phosphate Buffer, pH 7.2 |
900 |
5, 10, 15, 20 and 30 |
2015/06/25 |
| Ibuprofen/Diphenhydramine |
Capsule |
I (Basket) |
100 |
Phosphate Buffer (200 mM), pH7.2 |
900 |
10, 20, 30 and 45 |
2007/01/03 |
| Ibuprofen/Oxycodone HCl |
Tablet |
I (Basket) |
100 |
Phosphate buffer, pH 7.2 |
500 |
10, 20, 30 and 45 |
2007/04/09 |
| Ibuprofen/Phenylephrine HCl |
Tablet |
II (Paddle) |
50 |
50 mM Potassium Phosphate Buffer, pH 6.5, (degassed) |
900 |
10, 15, 20, 30 and 45 |
2012/01/05 |
| Ibuprofen/Pseudoephedrine HCl |
Capsule |
I (Basket) |
150 |
Tier 1: 0.05 M phosphate buffer, pH 7.2
Tier 2: 0.05 M phosphate buffer, pH 7.2 with NMT 1750 USP protease units/L of 1 X USP pancreatin |
900 |
10, 20, 30 and 45 |
2006/03/04 |
| Ibuprofen/Pseudoephedrine HCl |
Suspension |
II (Paddle) |
50 |
0.05 M Phosphate Buffer, pH 7.2 |
900 |
5, 10, 15 and 30 |
2004/02/04 |
| Idelalisib |
Tablet |
II (Paddle) |
75 |
0.01 N HCl |
750 |
5, 10, 15, 20 and 30 |
2015/08/27 |
| Iloperidone |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
500 |
5, 10, 15, 30, 45 and 60 |
2010/08/05 |
| Imatinib Mesylate |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
1000 |
5, 10, 15, 20 and 30 |
2011/09/22 |
| Imipramine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Imipramine Pamoate |
Capsule |
I (Basket) |
100 |
0.1 N HCl without pepsin and with 0.3% pepsin (addition of pepsin is recommended only when significant slow dissolution is observed) |
900 |
30, 60, 90, 120, 150 and 180 |
2008/01/14 |
| Indapamide |
Tablet |
|
|
Refer to USP |
|
|
2008/04/15 |
| Indinavir Sulfate |
Capsule |
II (Paddle) |
50 |
0.1 M Citrate Buffer, pH 3.8 |
900 |
10, 15, 20 and 30 |
2004/02/04 |
| Indomethacin |
Suspension |
|
|
Refer to USP |
|
|
2024/05/31 |
| Indomethacin |
Rectal Suppository |
|
|
Refer to USP |
|
|
2021/08/26 |
| Indomethacin |
Capsule (Extended Release) |
|
|
Refer to USP |
|
|
2007/07/25 |
| Indomethacin (40 mg and 20 mg) |
Capsule |
I (Basket) |
100 |
10 mM citric acid buffer, pH 5.75 |
750 |
5, 10, 15, 20 and 30 |
2015/05/28 |
| Indomethacin (50 and 25 mg) |
Capsule |
|
|
Refer to USP |
|
|
2015/05/28 |
| Infigratinib Phosphate |
Capsule |
I (Basket) |
100 |
0.01 N HCl |
900 |
15, 30, 45 and 60 |
2023/05/18 |
| Irbesartan |
Tablet |
|
|
Refer to USP |
|
|
2008/08/11 |
| Isavuconazonium Sulfate |
Capsule |
II (Paddle) with sinker |
75 |
Diluted McIlvaine Buffer [12.5 mM disodium hydrogen phosphate solution +6.25 mM citric acid solution ] + 0.5 % Sodium Lauryl sulfate (SLS) |
900 |
10, 20, 30, 45, 60, 75 and 90 |
2016/03/17 |
| Isocarboxazid |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 20, 30, 45 and 60 |
2004/02/04 |
| Isoniazid |
Tablet |
|
|
Refer to USP |
|
|
2008/04/15 |
| Isosorbide Dinitrate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Isosorbide Dinitrate |
Capsule (Extended Release) |
|
|
Refer to USP |
|
|
2015/06/25 |
| Isosorbide Dinitrate |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Isosorbide Dinitrate/Hydralazine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2021/08/19 |
| Isosorbide Mononitrate |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Isosorbide Mononitrate |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Isotretinoin |
Capsule |
|
|
Refer to USP |
|
|
2021/04/22 |
| Isradipine |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Isradipine |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Istradefylline |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Itraconazole |
Capsule |
II (Paddle) |
100 |
SGF without Enzyme |
900 |
10, 20, 30, 45, 60 and 90 |
2004/02/04 |
| Itraconazole |
Tablet |
II (Paddle) |
75 |
0.1 N HCl |
900 |
5, 15, 30, 45, 60, 75 and 90 |
2013/08/15 |
| Ivabradine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Ivacaftor |
Tablet |
II (Paddle) with sinker |
65 |
50 mM Sodium Phosphate Buffer with 0.7% Sodium Dodecyl Sulfate (SDS), pH 6.8 |
900 |
5, 10, 15, 20 and 30 |
2015/06/25 |
| Ivacaftor/lumacaftor |
Tablet |
Lumacaftor: II (Paddle); Ivacaftor: II (Paddle) |
Lumacaftor:65; Ivacaftor: 65 |
Lumacaftor: 0.5% (w/v) CTAB in 50 mM Sodium Acetate Trihydrate buffer (pH 4.5); Ivacaftor: 0.4% (w/v) SLS in 50 mM Sodium Phosphate buffer (pH 6.8) |
Lumacaftor: 900; Ivacaftor: 900 |
5, 10, 15, 20 and 30 |
2016/03/17 |
| Ivacaftor/Tezacaftor [FDC: IVA+ TEZ]; Ivacaftor [IVA] |
Tablet/Tablet (Copackage) |
II (Paddle) with option to use a sinker |
FDC: IVA: 65/TEZ:75; IVA: 65 |
FDC: IVA: 50 mM Sodium Phosphate Buffer with 0.4% Sodium Dodecyl Sulfate (SDS), pH 6.8/TEZ: 0.2 SDS% in 0.1 N HCl; IVA: 50 mM Sodium Phosphate Buffer with 0.7% SDS, pH 6.8; |
FDC: IVA: 900/ TEZ: 900; IVA: 900 |
5, 10, 15, 20, 30 and 45 |
2019/03/07 |
| Ivermectin |
Tablet |
II (Paddle) |
50 |
0.5% SDS in 0.01 M Monobasic Sodium Phosphate, pH 7.0 |
900 |
10, 20, 30, 45 and 60 |
2004/02/04 |
| Ivosidenib |
Tablet |
II (Paddle) |
50 |
50 mM Phosphate Buffer pH, 6.8 with 0.6% sodium dodecyl sulfate (SDS), |
900 |
10, 15, 20, 30 and 45 |
2020/08/27 |
| Ixazomib Citrate |
Capsule |
I (Basket) |
100 |
0.1 N HCl |
500 |
5, 10, 15, 20 and 30 |
2016/10/20 |
| Ketoconazole |
Tablet |
I (Basket) |
100 |
Simulated gastric fluid w/o pepsin |
800 |
15, 30, 45, 60 and 90 |
2007/01/03 |
| Ketoprofen |
Tablet |
II (Paddle) |
50 |
SIF Buffer without enzyme, pH 7.4 |
900 |
10, 20, 30, 45 and 60 |
2004/02/05 |
| Ketoprofen |
Capsule |
II (Paddle with sinker) |
50 |
0.05M Potassium Phosphate Buffer, pH 7.4 |
1000 |
10, 20, and 30 |
2023/02/09 |
| Ketorolac Tromethamine |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Labetalol HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Lacosamide |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Lacosamide |
Capsule (Extended Release) |
I (Basket) |
100 |
Phosphate Buffer, pH 6.8 |
900 |
0.5, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours |
2024/05/31 |
| Lamivudine |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Lamivudine 150 mg/Zidovudine 300mg Tablets and Abacavir Sulfate 300 mg Tablets-co-packaged |
Tablet |
II (Paddle) |
75 |
0.1 N HCl |
900 |
5, 10, 15, 20, 30 and 40 |
2007/01/03 |
| Lamivudine/Raltegravir Ka |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Lamivudine/Stavudine/Nevirapine |
Tablet |
II (Paddle) |
75 |
0.1 N HCl |
900 |
10, 20, 30, 45 and 60 |
2007/01/03 |
| Lamivudine/Zidovudine |
Tablet |
|
|
Refer to USP |
|
|
2017/11/02 |
| Lamivudine/Zidovudine + Efavirenz |
Tablet (Copackage) |
II (Paddle) |
Lamivudine and Zidovudine: 75 |
Lamivudine and Zidovudine: 0.1 N HCl Efavirenz: Develop a dissolution method |
Lamivudine and Zidovudine: 1000 |
10, 20, 30, and 45 |
2023/09/15 |
| Lamivudine/Zidovudine + Nevirapine |
Tablet (Copackage) |
II (Paddle) |
50 |
Lamivudine and Zidovudine: Develop a dissolution method Nevirapine: 0.06 M HCl (pH 1.2) |
900 |
10, 15, 30, 45 and 60 |
2023/09/15 |
| Lamivudine/Zidovudine/ Nevirapine |
Tablet |
II (Paddle) |
50 |
0.01 N HCl |
900 |
10, 15, 30, 45 and 60 |
2007/01/03 |
| Lamotrigine |
Tablet (Extended Release) |
|
|
Refer to USP |
|
|
2016/02/18 |
| Lamotrigine |
Tablet, For Suspension |
|
|
Refer to USP |
|
|
2023/02/09 |
| Lamotrigine |
Tablet (Regular) |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20 and 30 |
2006/03/04 |
| Lamotrigine |
Tablet (Chewable dispersible) |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20 and 30 |
2008/01/14 |
| Lansoprazole |
Capsule (Delayed Release) |
|
|
Refer to USP |
|
|
2008/11/04 |
| Lansoprazole |
Tablet (Delayed Release, Orally Disintegrating) |
II (Paddle) |
75 |
Acid Stage: 0.1 N HCl; Buffer Stage: Phosphate Buffer, pH 6.8 with 5 mM Sodium Dodecyl Sulfate |
500 (Acid), 900 (Buffer) |
60 (Acid), 10, 20, 30 and 45 (Buffer) |
2008/11/04 |
| Lanthanum Carbonate |
Chewable Tablet |
Reciprocating Cylinder (Apparatus 3 modified) |
10 dpm (dip rate per minute) |
0.25 N HCl |
900 (modified from the standard apparatus 3 vessel to achieve sink condition) |
10, 20, 30 and 45 |
2007/01/03 |
| Lapatinib Ditosylate |
Tablet |
II (Paddle) |
55 |
2% Polysorbate 80 in 0.1 N HCl |
900 |
10, 15, 30 and 45 |
2009/10/30 |
| Lasmiditan Succinate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2022/05/12 |
| Ledipasvir/Sofosbuvir |
Pellets |
II (Paddle) |
75 |
1.0% polysorbate 80 in 25 mM Potassium Phosphate Buffer, with 0.005 mg/mL Butylated Hydroxytoluene (BHT), pH 5.5 |
900 |
5, 10, 15, 20, 30, 45 and 60 |
2021/08/19 |
| Ledipasvir/Sofosbuvir |
Tablet |
II (Paddle) |
75 |
1.5% Polysorbate 80 in 10 mM Potassium Phosphate Buffer with 0.0075 mg/mL Butylated Hydroxytoluene (BHT), pH 6.0 |
900 |
5, 10, 15, 20, 30, 45 and 60 |
2015/08/27 |
| Lefamulin Acetate |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
1000 |
10, 20, 30, 45, 60, 75, and 90 |
2021/04/22 |
| Leflunomide |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Leflunomide (100 mg) |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Lemborexant |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20 and 30 |
2022/05/12 |
| Lenacapavir Sodium |
Tablet |
II (Paddle) with sinkers |
75 |
30 mM potassium phosphate, pH 6.0 with 2.0% Cremophor EL |
900 |
10, 15, 20, 25, 30, 45 and 60 |
2024/02/05 |
| Lenalidomide |
Capsule |
II (Paddle) |
50 |
0.01 N HCl |
900 |
10, 15, 20, 30 and 45 |
2008/04/15 |
| Leniolisib Phosphate |
Tablet |
I (Basket) |
100 |
Acetate Buffer, pH 4.0 |
900 |
10, 20, 30, 40, 50, 60, 70 and 80 |
2024/08/05 |
| Lenvatinib Mesylate |
Capsule |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20 and 30 |
2016/03/17 |
| Lesinurad |
Tablet |
II (Paddle) |
75 |
pH 4.5 sodium acetate buffer with 1% SLS |
900 |
10, 20, 30 and 45 |
2016/03/17 |
| Letermovir |
Tablet |
II (Paddle) |
75 |
25 mM Na Acetate Buffer, pH 4.5 with 0.6% Tween-80 |
900 |
10, 15, 20, 30, 45 and 60 |
2018/02/08 |
| Letrozole |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Letrozole (LET); Ribociclib Succinate (RIB) |
Tablet/Tablet (Copackage) |
II (Paddle) |
RIB: 50; LET: 75 |
RIB: 0.01 N HCl; LET: 0.1 N HCl |
RIB: 900; LET: 900 |
5, 10, 15, 20, 30 and 45 |
2019/03/07 |
| Leucovorin Calcium |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Leuprolide Acetate |
Implant |
|
|
Develop a method to characterize in vitro releas |
|
|
2022/05/12 |
| Leuprolide Acetate |
Injectable (Extended Release) |
|
|
Develop a dissolution method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency |
|
|
2010/01/15 |
| Leuprolide Mesylate |
Emulsion |
|
|
Develop a method to characterize in vitro release |
|
|
2023/10/06 |
| Levetiracetam |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Levetiracetam |
Tablet, for Suspension |
II (Paddle) |
50 |
Phosphate Buffer, pH 6.8 (degas) |
900 |
2.5, 5, 10, 15 and 20 |
2017/03/02 |
| Levetiracetam (1 g and 1.5 g) |
Tablet (Extended Release) |
III (Reciprocating Cylinder) |
15 dips/min |
Sodium acetate buffer, pH 4.5 |
900 |
1, 2, 4, 6, 8, 10 and 12 hours |
2024/11/01 |
| Levetiracetam (500 mg and 750 mg) |
Tablet (Extended Release) |
I (Basket) |
100 |
0.05 M Phosphate Buffer, pH 6.0 |
900 |
1, 2, 4, 6, 8 and 12 hours |
2009/04/02 |
| Levocarnitine |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Levocetirizine Dihydrochloride |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Levofloxacin |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Levomilnacipran HCl |
Capsule (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Levonorgestrel |
Intrauterine Device |
|
|
Develop a method to characterize in vitro release |
|
|
2014/02/14 |
| Levonorgestrel |
Tablet |
II (Paddle) |
75 |
0.1 N HCl with 0.1% SLS |
1000 |
10, 20, 30, 45, 60 and 90 |
2004/02/05 |
| Levorphanol Tartrate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2021/04/22 |
| Levothyroxine Sodium |
Tablet |
|
|
Refer to USP |
|
|
2007/07/25 |
| Lidocaine |
Topical Patch |
Paddle over Disk (Apparatus 5) |
50 |
Acetic acid/sodium acetate buffer, pH 4.0 at 32ºC |
500 |
10, 20, 30, 60, 120 and 180 |
2007/01/03 |
| Linaclotide |
Capsule |
I (Basket) |
50 |
50 mM Phosphate Buffer, pH 4.5 |
500 |
5, 10, 15, 20 and 30 |
2015/12/24 |
| Linagliptin |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Linagliptin/Metformin HCl |
Tablet (Extended Release) |
I (Basket) |
100 |
Simulated Gastric Fluid (SGF) without enzyme (pH 1.2) (degassed) |
900 |
Linagliptin 10, 15, 20, 30 and 45 minutes; Metformin: 1, 2, 4, 6, 8 and 12 hours |
2016/07/28 |
| Linagliptin/Metformin HCl |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20, 30 and 45 |
2014/05/15 |
| Linezolid |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Linezolid |
Suspension |
II (Paddle) |
50 |
0.05 M Phosphate Buffer, pH 6.8 |
900 |
10, 20, 30 and 45 |
2008/01/14 |
| Liothyronine Sodium |
Tablet |
|
|
Refer to USP |
|
|
2007/06/18 |
| Lisdexamfetamine Dimesylate |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Lisinopril |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Lithium Carbonate |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Lithium Carbonate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Lithium Carbonate |
Tablet (Extended Release) |
|
|
Refer to USP |
|
|
2008/01/14 |
| Lomefloxacin HCl |
Tablet |
II (Paddle) |
50 |
0.01 N HCl |
900 |
10, 20, 30 and 45 |
2004/02/05 |
| Lomitapide Mesylate |
Capsule |
II (Paddle) |
50 |
0.001 N HCl with 0.1% Polysorbate 80 |
500 mL (5 mg strength); 1000 mL (10 and 20 mg strength) |
5, 10, 20, 30 and 45 |
2015/06/25 |
| Lomustine |
Capsule |
|
|
Develop a dissolution method |
|
|
2015/12/24 |
| Lonafarnib |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Loperamide HCl |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Loperamide HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Loperamide HCl |
Oral Suspension |
II (Paddle) |
25 |
0.01 N HCl |
900 |
10, 20, 30, 45, 60, 75 and 90 |
2015/06/25 |
| Loperamide HCl |
Tablet (Chewable) |
II (Paddle) |
50 |
0.2 M Acetate Buffer, pH 4.7 |
500 |
5, 10, 15, 20 and 30 |
2015/06/25 |
| Loperamide HCl/Simethicone |
Tablet |
II (Paddle) |
75 |
0.1N HCl |
500 |
10, 15, 20, 30 and 45 |
2015/08/27 |
| Loperamide HCl/Simethicone |
Tablet (Chewable) |
II (Paddle) |
50 |
0.2 M Acetate Buffer, pH 4.7 |
500 |
5, 10, 15, 20 and 30 |
2023/02/09 |
| Lopinavir/Ritonavir |
Tablet (Combination) |
|
|
Refer to USP |
|
|
2015/01/15 |
| Lopinavir/Ritonavir |
Capsule (Soft-Gelatin) |
II (Paddle) |
50 |
Tier 1: 0.05 M Polyoxyethylene 10 Lauryl Ether with 10 mM Sodium Phosphate monobasic (pH 6.8); Tier II: same as above with NMT 1750 USP units/L of Pancreatin |
900 |
10, 15, 30 and 45 |
2007/06/18 |
| Loratadine |
Tablet (Chewable) |
II (paddle) |
50 |
0.1 N HCl |
500 |
15, 30, 45 and 60 |
2008/07/14 |
| Loratadine |
Tablet (Orally Disintegrating) |
I (Basket) |
50 |
SGF without enzyme |
900 |
2, 4, 6 and 10 |
2008/07/14 |
| Loratadine |
Capsule (Soft-Gelatin) |
II (Paddle) with sinker |
75 |
Tier I: 0.1N HCl with 0.1% Tween 20. Tier II: 0.1N HCl with 0.1% Tween 20 with addition of pepsin (as per USP). |
900 |
10, 20, 30, 45 and 60 |
2013/02/28 |
| Loratadine/Pseudoephedrine Sulfate (10 mg /240 mg) |
Tablet (Extended Release) |
I (Basket) |
75 |
900 mL 0.1 N HCl for one hour, then replace the medium with 900 mL 0.05 M phosphate buffer at pH6.8 containing 0.01% sodium lauryl sulfate. |
900 |
Loratadine:10, 15, 20, 30 and 45; Pseudoephedrine: 1, 2, 4, 8, 12, 16, 18 and 24 hours |
2010/08/05 |
| Loratadine/Pseudoephedrine Sulfate (5 mg /120 mg) |
Tablet (Extended Release) |
II (Paddle) |
50 |
900 mL 0.1 N HCl for one hour, then replace with 900 mL 0.05 M phosphate buffer at pH 8.2 containing 0.01% sodium lauryl sulfate |
900 |
Loratadine:15, 20, 30, 45, 60 and 90; Pseudoephedrine: 1, 2, 4, 8, 12 and 16 hours |
2010/08/05 |
| Lorazepam |
Capsule (Extended Release) |
I (Basket) |
100 |
Acid Stage: 0.1N HCl; Buffer stage: Sodium Phosphate Buffer, pH 7.4 |
Acid stage: 700; Buffer stage: 1000 |
Acid stage: 0.5, 1 and 2 hours; Buffer stage: 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours |
2022/05/12 |
| Lorazepam |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Lorcaserin HCl |
Tablet (Extended Release) |
I (Basket) |
100 |
0.1 N HCl (deaerated) |
900 |
1, 2, 4, 5, 8 12, 16 and 20 hours |
2016/10/20 |
| Lorcaserin HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Losartan Potassium |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Loteprednol Etabonate |
Ophthalmic Suspension |
|
|
Develop a method to characterize in vitro release |
|
|
2016/06/30 |
| Loteprednol Etabonate/Tobramycin |
Ophthalmic Suspension |
|
|
Develop a method to characterize in vitro release |
|
|
2013/01/31 |
| Lovastatin |
Tablet (Extended Release) |
II (Paddle) |
50 |
0.5% sodium lauryl sulfate (SLS) / sodium phosphate buffer (0.01M), pH 6.5 |
900 |
1, 2, 4, 6, 8, 12, 16 and 20 hours |
2019/02/07 |
| Lovastatin/Niacin |
Tablet (Extended Release) |
I (Basket) |
100 |
For Niacin: Develop a dissolution method; for Lovastatin: 0.05 M phosphate buffer, pH 7.0 with 0.5% sodium dodecyl sulfate |
900 |
For Lovastatin: 15, 30, 45 and 60 min |
2023/09/15 |
| Lubiprostone |
Capsule (Soft-Gelatin) |
II (Paddle) |
50 |
0.1 N HCl/1% HCO-40 (Polyoxyl 40 hydrogenated castor oil) |
900 |
15, 30, 45, 60, 90 and 120 |
2010/08/19 |
| Lurasidone HCl |
Tablet |
II (Paddle) |
50 |
McIlvaine buffer, pH 3.8 [(0.025 M Citric acid Solution + 0.05M Na2HPO4 solution (3:2)] Measure the pH and adjust to 3.8, if necessary. Degas before use. |
900 |
5, 10, 15, 20 and 30 |
2013/01/31 |
| Macitentan |
Tablet |
II (Paddle) |
75 |
Phosphate Buffer, pH 6.8
with 0.1% of Cetrimonium bromide (CTAB) |
900 |
10, 15, 20, 30 and 45 |
2015/05/28 |
| Macitentan (MAC); Tadalafil (TAD) |
Tablet |
II (Paddle) |
60 |
MAC: 0.05 M sodium phosphate buffer, pH 5.5 with 0.30% (w/v) CTAB; (TAD):0.05 M sodium phosphate buffer, pH 6.8
with 3.0% (w/v) polysorbate 20 |
900 |
5, 10, 15, 20, 30, 45 and 60 |
2024/08/05 |
| Magnesium Hydroxide/Omeprazole/Sodium Bicarbonate |
Tablet (Chewable) |
II (Paddle) |
150 |
0.029 M sodium phosphate buffer w/ 0.5% SDS, pH 7.4 |
900 |
15, 30, 45, and 60 |
2008/02/19 |
| Magnesium Hydroxide/Omeprazole/Sodium Bicarbonate |
Tablet (Chewable) |
II (Paddle) |
150 |
pH 7.4 Phosphate Buffer with 0.5% SDS |
900 |
15, 30, 45, 60 and 90 |
2008/10/06 |
| Magnesium Sulfate/Potassium Chloride/Sodium Sulfate |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Maraviroc |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Maribavir |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20 and 45 |
2023/07/07 |
| Maribavir |
Tablet |
II (Paddle) |
50 |
0.1N HCl (deaerated) |
900 |
10, 15, 20, 30 and 45 |
2023/02/09 |
| Mavacamten |
Capsule |
II (Paddle) |
50 |
Tier 1: 0.05%(w/v) SDS in 50 mM Sodium Phosphate, pH 6.8; Tier 2: 50 mM sodium phosphate, pH 6.8, containing NMT 2,000 unit/L of pancreatin (850 mL). After 10 minutes, add 50 mL of 50 mM sodium phosphate, pH 6.8, containing 0.9% (w/v) SDS |
900 |
10, 15, 30, 45 and 60 |
2023/05/18 |
| Mebendazole |
Tablet (Chewable) |
II (Paddle) |
75 |
0.1 N HCl containing 1% Sodium Lauryl Sulfate |
900 |
15, 30, 45, 60, 90 and 120 |
2008/10/06 |
| Mebendazole ( 500 mg) |
Tablet (Chewable) |
II (Paddle) |
75 |
1% Sodium Lauryl Sulfate (SLS) in 0.01 N HCl |
900 |
5, 10, 15,
30, 45 and 60 |
2016/12/22 |
| Mecamylamine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Meclizine HCl |
Tablet |
I (Basket) |
100 |
0.01 N HCl |
900 |
10, 20, 30, 45 and 60 |
2009/08/27 |
| Meclizine HCl |
Tablet (Chewable) |
I (Basket) |
100 |
0.01 N HCl |
900 |
10, 20, 30, 45 and 60 |
2010/04/08 |
| Medroxyprogesterone Acetate |
Injectable Suspension |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Medroxyprogesterone Acetate |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Medroxyprogesterone Acetate (104mg/0.65ml) |
Injectable Suspension |
|
|
Develop a method to characterize in vitro release |
|
|
2018/02/08 |
| Mefenamic Acid |
Capsule |
|
|
Refer to USP |
|
|
2009/12/15 |
| Mefloquine HCl |
Tablet |
I (Basket) |
100 |
SGF without enzyme |
900 |
10, 20, 30, 45 and 60 |
2004/02/06 |
| Megestrol Acetate |
Oral Suspension |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Meloxicam |
Capsule |
I (Basket) |
100 |
Phosphate Buffer, pH 6.1 with 0.1% Sodium Lauryl Sulfate (SLS) |
500 mL (for 5 mg); 1000 mL (for 10 mg) |
5, 10, 15, 20 and 30 |
2016/06/30 |
| Meloxicam |
Suspension |
II (Paddle) |
25 |
Phosphate buffer at pH 7.5 |
900 |
5, 10, 15 and 30 |
2006/01/26 |
| Meloxicam |
Tablet |
II (Paddle) |
75 |
Phosphate Buffer, pH 7.5 |
900 |
10, 20, 30, 45 and 60 |
2004/02/20 |
| Melphalan |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Memantine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Memantine HCl |
Tablet (Orally Disintegrating) |
I (Basket) |
100 |
0.1 N HCl |
900 |
15, 30, 25 and 60 |
2024/11/01 |
| Memantine HCl |
Capsule (Extended Release) |
I (Basket) |
100 |
pH 1.2 NaCl/HCl Buffer (degas) |
900 |
1, 2, 3, 4, 6, 8, 10 and 12 hours |
2017/03/02 |
| Menthol/Methyl Salicylate |
Topical Patch |
VI (Cylinder) |
50 |
Neutralized phthalate buffered solution (0.2 M potassium biphthalate) with pH of 5.0 at 32 ± 0.5°C |
900 |
10, 20, 30, 60, 120, 150 and 180 |
2013/01/31 |
| Meprobamate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Mercaptopurine |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
20, 30, 45, 60, 90 and 120 |
2004/02/06 |
| Mercaptopurine |
Oral Suspension |
II (Paddle) |
50 |
0.1N HCl |
900 |
5, 10, 15, 20 and 30 |
2015/12/24 |
| Mesalamine |
Suppository |
II (Paddle) with option to use a sinker |
75 (for 500 mg) & 125 (for 1000 mg) |
For 500 mg strength:
0.2 M Phosphate buffer, pH 7.5 at 37 deg. C
For 1000 mg strength:
0.2 M Phosphate buffer, pH 7.5 at 40 deg. C |
900 |
30, 60, 90, 120 and 150 |
2006/01/30 |
| Mesalamine |
Capsule (Delayed Release) |
II (Paddle) |
Phase 1 & 2: 100 rpm; Phase 3: 50 rpm |
Phase 1: 0.1N HCl (degas); Phase 2: pH 6.0 Buffer (degas); Phase 3: pH 7.2 Buffer |
Phase 1: 500; Phase 2: 900; Phase 3: 900 |
Phase 1: 120; Phase 2: 60; Phase 3: 20, 30, 45, 60, 75, 90 and 120 |
2016/06/30 |
| Mesalamine (1.2 gram) |
Tablet (Delayed Release) |
II (Paddle) |
100 |
Acid stage (A): 100 mM HCl Buffer stage (B): Phosphate Buffer, pH 6.4 Buffer stage (C): Phosphate Buffer, pH 7.2 |
Acid stage (A): 750 mL; Buffer stage (B): 950 mL; Buffer stage (C): 960 mL |
Acid stage (A): 2 hours; Buffer stage (B): 1 hour; Buffer stage (C): 1, 2, 4, 6 and 8 hours |
2009/06/10 |
| Mesalamine (250 mg and 500 mg) |
Capsule (Extended Release) |
|
|
Refer to USP |
|
|
2009/06/10 |
| Mesalamine (375 mg) |
Capsule (Extended Release) |
I (Basket) |
100 |
Acid Stage: 0.1N HCl Buffer stage: Phosphate Buffer, pH 6.8 |
Acid stage: 750 mL; Buffer stage: 1000 mL |
Acid stage: 2 hours; Buffer stage: 0.5, 1, 2, 4, 7 and 9 hours |
2009/06/10 |
| Mesalamine (400 mg and 800 mg) |
Tablet (Delayed Release) |
|
|
Refer to USP |
|
|
2010/11/05 |
| Mesalamine Enema |
Rectal Enema |
II (Paddle) |
50 |
Phosphate Buffer, pH 7.2 |
900 |
5, 10, 15, and 30 |
2007/06/18 |
| Mesna |
Tablet |
II (Paddle) |
50 |
0.06 N HCl |
500 |
5, 10, 15, 20 and 30 |
2004/02/09 |
| Mestranol/Norethindrone |
Tablet |
|
|
Refer to USP |
|
|
2010/03/25 |
| Metaxalone |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Metformin HCl |
For Suspension (Extended Release) |
II (Paddle) |
100 |
Phosphate Buffer, pH 6.8 |
1000 |
0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours |
2020/01/30 |
| Metformin HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Metformin HCl |
Tablet (Extended Release) |
|
|
Refer to USP |
|
|
2008/12/12 |
| Metformin HCl (MET); Sitagliptin (SIT) |
Tablet (Extended Release) |
II (Paddle) with sinker |
75 |
Phosphate buffer, pH 6.8 |
900 |
MET: 1, 2, 3, 4, 6, 8, 10, and 12 hours; SIT: 10, 20, 30, 45 and 60 |
2023/07/07 |
| Metformin HCl/Pioglitazone HCl |
Tablet |
II (Paddle) |
50 |
pH 2.5 McIlvaine buffer (0.1 M Citric acid adjusted to pH 2.5 with 0.2 M Na2HPO4) |
900 |
10, 20, 30 and 45 |
2007/01/03 |
| Metformin HCl/Saxagliptin |
Tablet (Extended Release) |
I (Basket) |
100 |
Phosphate Buffer, pH 6.8 |
1000 |
Metformin: 1, 2, 3, 4, 6, 8, 10 and 12 hours. Saxagliptin: 5, 10, 15, 20 and 30 minutes |
2012/01/26 |
| Metformin HCl/Sitagliptin Phosphate |
Tablet |
II (Paddle) |
75 |
0.025 M NaCl |
900 |
10, 15, 20 and 30 |
2008/10/06 |
| Metformin/Repaglinide |
Tablet |
II (Paddle) |
50 |
Citric acid/phosphate buffer, pH 5.0 |
900 |
5, 10, 15, 20 and 30 |
2009/10/30 |
| Methadone HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Methazolamide |
Tablet |
II (Paddle) |
100 |
pH 4.5 Acetate Buffer |
900 |
10, 15, 20, 30 and 45 |
2015/05/28 |
| Methenamine Hippurate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Methimazole |
Tablet |
|
|
Refer to USP |
|
|
2008/01/14 |
| Methocarbamol |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Methotrexate Sodium |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Methoxsalen |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Methscopolamine Bromide |
Tablet |
|
|
Refer to USP |
|
|
2018/02/15 |
| Methylergonovine Maleate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Methylnaltrexone Bromide |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Methylphenidate |
Capsule (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Methylphenidate |
Transdermal Patch |
VI (Cylinder) |
50 |
0.01 N HCl at 32ºC |
900 |
0.5, 1.5, 3, 4 hours and until at least 80% released |
2008/04/15 |
| Methylphenidate |
Tablet (Extended Release, Orally Disintegrating ) |
II (Paddle) |
75 |
Acid Stage: 0.1 N HCl; Buffer Stage: Phosphate Buffer, pH 6.8 |
Acid Stage: 900 mL; Buffer Stage: 1000 mL |
Acid Stage: 15, 30, 60, 120 minutes; Buffer Stage: 1, 2, 3, 4, 6 and 8 hours |
2017/11/16 |
| Methylphenidate |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Methylphenidate (BX) |
Capsule (Extended Release) |
I (Basket) |
75 |
0-2 hrs:0.01 N HCl. 2-10 hrs: Phosphate Buffer, pH 6.8. |
0-2 hrs: 500. 2-10 hrs:500 |
0.5, 1, 3, 6, 8 and 10 hours |
2007/07/25 |
| Methylphenidate HCl |
Capsule (Extended Release) |
I (Basket) |
100 |
Acid Stage:(First 2 hours) 0.01 N HCl; Buffer Stage (2-10 hours): Phosphate Buffer, pH 6.0 |
Acid: 500 mL; Buffer: 500 mL |
0.5, 1, 2, 4, 6, and 10 hours |
2016/10/20 |
| Methylphenidate HCl |
Tablet (Chewable) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Methylphenidate HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Methylphenidate HCl |
Tablet (Extended Release, Chewable) |
II (Paddle) |
75 |
0.4M KH2PO4 solution (degas) |
900 |
0.25, 0.5, 1, 2, 3, 4, 6, 8 hours |
2016/03/17 |
| Methylphenidate HCl |
Powder for Suspension (Extended Release) |
II (Paddle) |
75 |
0.4 M Phosphate Buffer, pH 4.5 |
900 |
0.25, 0.5, 1, 2, 3, 4, 6 and 8 hours |
2016/06/02 |
| Methylphenidate HCl (25 mg, 35 mg, 45 mg, 55 mg, 70 mg and 85 mg) |
Capsule (Extended Release) |
II (Paddle) with sinker |
75 |
Acid Stage:(0-6 hours) Simulated Gastric Fluid [SGF, pH 1.2] without enzyme; Buffer Stage (after six hours in acid stage): Phosphate Buffer, pH 7.4 |
|
Acid Stage: 0.5, 1, 2, 4, 6 hours; Buffer Stage: 1, 2, 4, 6, 8 and 10 hours |
2020/04/02 |
| Methylprednisolone |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Methylprednisolone Acetate |
Injectable Suspension |
IV (Flow-Through Cell-Open system) |
|
0.55 % SDS |
|
15, 30, 45, 60, 90 and 120 |
2009/10/08 |
| Methyltestosterone |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Methyltestosterone |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Metoclopramide HCl |
Tablet (Orally Disintegrating) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Metoclopramide HCl |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Metolazone |
Tablet |
|
|
Refer to USP |
|
|
2020/04/02 |
| Metoprolol Succinate |
Tablet (Extended Release) |
|
|
Refer to USP |
|
|
2007/07/25 |
| Metoprolol Tartrate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Metronidazole |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Metronidazole |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Metyrosine |
Capsule |
|
|
Refer to USP |
|
|
2018/02/15 |
| Mexiletine HCl |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2021/04/22 |
| Miconazole |
Tablet (Buccal) |
I (Basket) |
60 |
0.5% SDS (Sodium dodecylsulfate) in water-pH adjusted to 6.5 ± 0.5 |
1000 |
1, 2, 4, 6, 8, 10 and 12 hours |
2010/10/28 |
| Miconazole Nitrate |
Suppository (Vaginal) |
I (Basket) |
100 |
0.45% SLS in water |
900 |
15, 30, 45 and 60 |
2009/10/08 |
| Midodrine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Midostaurin |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Mifepristone |
Tablet |
II (Paddle) |
75 |
0.01 N HCl |
900 |
5, 10, 15, 20 and 30 |
2008/01/14 |
| Mifepristone [300 mg] |
Tablet |
II (Paddle) |
50 |
pH 1.8 KCl Buffer |
900 |
10, 15, 20, 30 and 45 |
2016/03/17 |
| Miglitol |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Miglustat |
Capsule |
I (Basket) |
100 |
0.1 N HCl |
1000 |
10, 20, 30 and 45 |
2007/01/03 |
| Milnacipran HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Miltefosine |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Minocycline HCl |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Minocycline HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Minocycline HCl |
Capsule (Extended Release) |
I (Basket- 10 mesh) |
100 |
0.1 N HCl |
900 |
0.25, 0.5, 1.0, 1.5, 2, 3 and 4 hours |
2016/06/02 |
| Minocycline HCl |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Minocycline HCl |
ER Tablets |
I (Basket) |
100 |
0.1 N HCl |
900 |
1, 2, 4, 6 hours and until 80% of drug released |
2008/01/14 |
| Minocycline HCl (135 mg and 105 mg) |
Tablet (Extended Release) |
I (Basket) |
100 |
pH 2.1 Buffer (Degassed) |
900 |
15, 30, 45, 60, 90, 120, 180 and 210 |
2017/11/02 |
| Minoxidil |
Tablet |
|
|
Refer to USP |
|
|
2008/04/15 |
| Mirabegron |
Granules, for Oral Suspension (Extended Release) |
II (Paddle) |
100 |
Stage 1: USP Phosphate Buffer (0.036 mol), pH 6.8 (0-4 hours); Stage 2: Phosphate Buffer pH 6.8 (0.108 mol), (after 4 hours) |
Stage 1: 500; Stage 2: 1000 |
0.25, 0.5, 1, 2, 4, 6, 8 and 10 hours |
2022/05/12 |
| Mirabegron |
Tablet (Extended Release) |
I (Basket) |
100 |
Phosphate Buffer, pH 6.8 |
900 |
1, 3, 5, 7, 8.5, 10 and 12 hours |
2013/05/09 |
| Mirtazapine |
Tablet (Orally Disintegrating (ODT)) |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20 and 30 |
2006/03/04 |
| Mirtazapine |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Misoprostol |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Mitapivat Sulfate |
Tablet |
II (Paddle) |
70 |
100 mM sodium phosphate, pH 6.8, with 0.05% w/w sodium dodecyl sulfate (SLS) |
900 |
5, 10, 15, 20 and 30 |
2023/03/30 |
| Mitotane |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Mobocertibib Succinate |
Capsule |
II (Paddle) |
50 |
0.05 M potassium chloride in 0.085 N hydrochloric acid, pH 1.2 |
500 |
10, 15, 20, 30, 45 and 60 |
2023/10/06 |
| Modafinil |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 20, 30, 45 and 60 |
2004/02/10 |
| Moexipril HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Molindone HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Monomethyl Fumarate |
Capsule (Delayed Release) |
II (Paddle) Stationary Basket over the Paddle |
100 |
Acid Stage: 0.1 N HCl; Buffer Stage: Phosphate buffer, pH 6.8 |
|
Acid Stage: 120; Buffer Stage: 15, 30, 45, 60, 90, 120 and 150 |
2020/08/27 |
| Montelukast |
Granule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Montelukast Sodium |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Montelukast Sodium |
Tablet (Chewable) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Morphine Sulfate |
Tablet (Extended Release) |
I (Basket) |
100 |
Simulated Gastric Fluid [SGF] without enzyme |
900 |
0.25, 0.5, 1, 1.5, 2, 4, 6 and 8 hours |
2016/10/20 |
| Morphine Sulfate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Morphine Sulfate |
Capsule (Extended Release) |
|
|
Refer to USP |
|
|
2008/08/11 |
| Morphine Sulfate/Naltrexone HCl |
Capsule (Extended Release) |
II (Paddle) |
50 |
Acid stage: 0.1 N HCl; Buffer stage: 0.05 Phosphate Buffer, pH 7.5 |
Acid stage: 500; Buffer stage: 500 |
Morphine Sulfate: Acid stage: 1 hour; Buffer stage: 1, 3, 5, 8 and 10 hours. Naltrexone HCl: Acid stage: 1 hour; Buffer stage: 1, 12, 24, 48, 73 and 96 hours. |
2012/01/26 |
| Moxifloxacin |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Mycophenolate Mofetil |
Suspension |
II (Paddle) |
40 |
0.1 N HCl |
900 |
5, 10, 20 and 30 |
2004/02/10 |
| Mycophenolate Mofetil |
Capsule |
II (Paddle) |
40 |
0.1 N HCl |
900 |
5, 10, 20 and 30 |
2004/02/10 |
| Mycophenolate Mofetil |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15 and 30 |
2004/02/10 |
| Mycophenolic acid |
Tablet (Delayed Release) |
II (Paddle) |
50 |
Acid Stage: 0.1 N HCl; Buffer Stage: Buffer Solution, pH 6.8 (After initial 120 mins., 250 mL of 0.2 M sodium phosphate solution is added to acid stage medium. The pH of the mixture is adjusted to 6.8 using 0.2 M sodium phosphate, 2 N sodium hydroxide, or concentrated HCl acid solution if necessary.) |
750 (Acid), 1000 (Buffer) |
120 (Acid), 10, 20, 30, 45 and 60 (Buffer) |
2008/12/19 |
| Nabilone |
Capsule |
II (Paddle) |
50 |
0.1% Tween 80 solution |
1000 |
15, 30, 45 and 60 |
2008/07/14 |
| Nabumetone |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Nadolol |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Naldemedine |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Naloxegol Oxalate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Naltrexone |
Injectable Suspension |
|
|
Phosphate buffered saline with 0.02% Tween 20 and 0.02% Sodium azide, pH 7.4 (final osmolality should be 270 ± 20 mOsm), or any other appropriate medium, at 37°C. Develop an in vitro release method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency |
|
|
2011/09/01 |
| Naltrexone HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Naltrexone HCl / Oxycodone HCl |
Capsule (Extended Release) |
|
|
Develop a dissolution method |
|
|
2016/12/22 |
| Naltrexone HCl/Bupropion HCl |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Naproxen |
Suspension |
|
|
Develop a dissolution method |
|
|
2017/11/16 |
| Naproxen |
Tablet (Delayed Release) |
|
|
Refer to USP |
|
|
2009/12/15 |
| Naproxen |
Tablet |
|
|
Refer to USP |
|
|
2007/07/25 |
| Naproxen Sodium |
Capsule |
II (Paddle) |
75 |
Sodium Phosphate Buffer, pH 7.4 ± 0.05 |
900 |
10, 15, 20, 30 and 45 |
2015/05/28 |
| Naproxen Sodium |
Tablet (Extended Release) |
II (Paddle) |
50 |
Phosphate Buffer, pH 7.5 |
900 |
0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 14 hours |
2010/04/08 |
| Naproxen Sodium |
Tablet |
|
|
Refer to USP |
|
|
2012/10/04 |
| Naproxen Sodium/Diphenhydramine HCl |
Tablet |
II (Paddle) |
75 |
0.1M Sodium Phosphate buffer, pH 7.4 (deaerated) |
900 |
5, 10, 15, 20 and 30 |
2015/06/25 |
| Naproxen Sodium/Diphenhydramine HCl |
Tablet |
II (Paddle) |
75 |
0.1M Sodium Phosphate Buffer, pH 7.4 |
900 |
5, 10, 15, 20, 30 and 45 |
2015/05/28 |
| Naproxen Sodium/Sumatriptan Succinate |
Tablet |
I (Basket) |
75 |
Phosphate Buffer, pH 6.8 |
900 |
10, 15, 20, 30 and 45 |
2010/07/01 |
| Naproxen/Esomeprazole Magnesium |
Tablet (Delayed Release) |
II (Paddle) with sinkers |
Naproxen::50 rpm Esomeprazole::75 rpm |
Naproxen:: Acid Stage: 0.1M HCl; Buffer Stage: 0.05M Phosphate buffer, pH 6.8.
Sampling for Acid stage: Transfer the un-dissolved tablet & sinker to the vessel containing the buffer stage medium. Add, 10 mL of 10 M NaOH to each vessel of the remaining acid stage medium. Continue rotation at 100 rpm for 30 minutes, withdraw aliquot and analyze.
Esomeprazole (second set of tablets)(without pre-exposure to acid stage):: 0.05M Phosphate buffer, pH 7.4 |
Naproxen::Acid Stage: 1000; Buffer Stage: 1000; Esomeprazole::900 |
Naproxen:: Acid stage: 120; Buffer stage: 10, 20, 30, 45, 60, 75 and 90; Esomeprazole::10, 20, 30, 45, 60, 75 and 90 |
2013/06/06 |
| Naratriptan HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Nateglinide |
Tablet |
II (Paddle) |
50 |
0.01 N HCl with 0.5% (w/v) SLS |
1000 |
10, 20, 30 and 45 |
2007/01/03 |
| Nebivolol HCl |
Tablet |
II (Paddle) |
50 |
0.01 N HCl |
900 |
10, 20, 30 and 45 |
2010/01/15 |
| Nebivolol/Valsartan |
Tablet |
I (Basket) |
100 |
67 mM Phosphate Buffer pH 6.8 with 0.5% SDS |
900 |
5, 10, 15, 20 and 30 |
2016/10/20 |
| Nefazodone HCl |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 20, 30, 45 and 60 |
2007/01/03 |
| Nelfinavir Mesylate |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20, 30, 45, 60 and 90 |
2007/01/03 |
| Nelfinavir Mesylate |
Powder for Suspension |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20, 30, and 45 |
2007/09/13 |
| Neomycin Sulfate |
Tablet |
II (Paddle) |
50 |
0.05 M Phosphate Buffer, pH 6.8 |
900 |
15, 30, 45 and 60 |
2008/01/14 |
| Nepafenac |
Ophthalmic Suspension |
|
|
Develop a method to characterize in vitro release |
|
|
2014/08/14 |
| Netupitant/Palonosetron HCl |
Capsule |
II (Paddle) |
Netupitant:100; Palonosetron: 75 |
Netupitant: 0.07M Phosphate buffer pH 6.8 containing 1% sodium SDS ; Palonosetron: 0.01 N HCl |
Netupitant: 900; Palonosetron: 500 |
Netupitant: 10, 20, 30, 45, 60 and 75; Palonosetron: 5, 10, 15, 20, 30 and 45 |
2015/09/03 |
| Nevirapine |
Suspension |
II (Paddle) |
25 |
0.1 N HCl |
900 |
10, 20, 30, 45 and 60 |
2004/02/11 |
| Nevirapine |
Tablet |
|
|
Refer to USP |
|
|
2007/09/13 |
| Nevirapine |
Tablet (Extended Release) |
I (Basket) |
75 |
0.04 M Sodium phosphate buffer pH 6.8 containing 2% sodium lauryl sulfate |
900 |
1, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 20 hours |
2013/01/31 |
| Niacin |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Niacin/Simvastatin |
Tablet (Extended Release) |
Simvastain: I (10 mesh rotating Basket) |
100 |
Niacin: Develop a dissolution method; Simvastatin: 0.5 % SDS in 0.01 M Sodium Phosphate, pH 7.0 |
900 |
Simvastatin: 10, 20, 30, 45 and 60 |
2023/09/15 |
| Nicardipine HCl |
Capsule |
II (Paddle) |
50 |
0.033 M Citric Acid Buffer, pH 4.5 |
900 |
10, 20, 30 and 45 |
2004/02/11 |
| Nicardipine HCl |
Capsule (Extended Release) |
II (Paddle) |
50 |
0.1 N HCl |
1000 |
0.5 , 2 and 6 hours |
2008/07/14 |
| Nicotine |
Film, Transdermal (Extended Release) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Nicotine Polacrilex |
Chewing Gum |
Chewing Machine as desribed in European Pharmacopoeia (2.9.25) |
60 cycles (chews) per minute |
Phosphate Buffer, pH 7.4 or or any other appropriate buffer and conditions |
20 |
5, 10, 20 and 30 |
2012/01/05 |
| Nicotine Polacrilex |
Lozenge |
I (Basket) |
100 |
Phosphate Buffer, pH 7.4 |
900 |
0.5, 1, 2, 3, 6 and 8 hours |
2010/12/23 |
| Nicotine Polacrilex |
Lozenge (Mini) |
III (Reciprocating Cylinder) |
20 dpm |
Phosphate buffer pH 7.4 |
250 |
15, 30, 45, 60 and 90 |
2017/03/09 |
| Nifedipine |
Capsule |
|
|
Refer to USP |
|
|
2011/03/03 |
| Nifedipine |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Nifurtimox |
Tablet |
II (Paddle) |
100 |
Acetate buffer pH 4.5 with 1% sodium dodecyl sulfate (SDS) for 30 mg strength and 1.5 % SDS for 120 mg strength |
900 |
15, 30, 45, 60, 90 and 120 |
2023/02/09 |
| Nifurtimox |
Tablet |
II (Paddle) |
100 |
Acetate Buffer, pH 4.5 with 1.0 % Sodium Dodecyl Sulfate (SDS) (for 30 mg strength) and 1.5 % SDS (for 120 mg strength) |
900 |
10, 20, 30, 60 and 75 |
2022/07/07 |
| Nilotinib HCl |
Capsule |
I (Basket) |
100 |
0.1 N HCl |
1000 |
10, 15, 20, 30 and 45 |
2024/02/05 |
| Nilotinib Hydrochloride Monohydrate |
Capsule |
I (Basket) |
100 |
0.1 N HCl |
1000 |
10, 15, 30 and 45 |
2009/10/30 |
| Nilutamide |
Tablet |
|
|
Develop a dissolution method |
|
|
2009/05/20 |
| Nimodipine |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Nintedanib Esylate |
Capsule |
II (Paddle) with sinker |
100 |
0.1 N HCl |
900 |
10, 15, 20, 30, 45 and 60 |
2015/09/03 |
| Niraparib |
Capsule |
II (Paddle) with sinker |
50 |
Tier 1: 0.08M Sodium Acetate Buffer, pH 4.0; Tier 2: 0.08M Sodium Acetate Buffer, pH 4.0 containing pepsin (750,000 units/L) |
900 |
10, 15, 20, 30, 45 and 60 |
2017/11/02 |
| Niraparib Tosylate |
Tablet |
II (Paddle) |
60 |
0.1 M Citrate buffer, pH 4.6 |
900 |
5, 10, 15, 20, 25, 30 and 45 |
2024/02/05 |
| Nirmatrelvir (NIR); Ritonavir (RIT) |
Tablet (copackage) |
II (Paddle) |
75 |
NIR: 0.05 M Sodium Phosphate, pH 6.8 with 0.2% Sodium Dodecyl Sulfate; RIT: Refer to USP |
900 |
15, 20, 30, 45 and 60 |
2024/08/05 |
| Nisoldipine |
Tablet (Extended Release) |
II (Paddle) with option to use a sinker |
50 |
HCl with SLS (32.5 ± 0.1 g Sodium Lauryl Sulfate in 6489 mL of purified water containing 17.0 mL HCl, pH adjusted to 1.20 ± 0.05 with HCl) |
900 |
1, 4, 8, 12, 15, 18 and 24 hours |
2009/04/02 |
| Nitazoxanide |
Tablet |
II (Paddle) |
75 |
Phosphate buffer at pH 7.5 with 6% hexadecyltrimethyl ammonium bromide, bath temperature at 25ºC |
900 |
10, 20, 30, 45, 60 |
2007/01/03 |
| Nitazoxanide |
Oral Suspension |
II (Paddle |
100 |
Phosphate buffer at pH 7.5 with 6% hexadecyltrimethyl ammonium bromide, bath temperature at 25ºC |
900 |
10, 20, 30, 45 and 60 |
2010/10/21 |
| Nitisinone |
Suspension |
II (Paddle) |
50 |
pH 1.2 HCl Buffer (degassed) |
1000 |
10, 15, 20, 30 and 45 |
2016/12/22 |
| Nitisinone |
Capsule |
II (Paddle) with sinker |
50 |
Phosphate Buffer, pH 6.8 |
1000 |
5, 10, 15, 20, 30 and 45 |
2017/11/02 |
| Nitisinone |
Tablet |
II (Paddle) |
50 |
Phosphate Buffer, pH 6.8 |
2 mg tablets: 500 mL; 5 mg and 10 mg tablets: 900 mL |
10, 15, 20, 30, 45, 60, 75 and 90 |
2018/02/15 |
| Nitrofurantoin |
Capsule |
|
|
Refer to USP |
|
|
2009/04/02 |
| Nitrofurantoin |
Suspension |
II (Paddle) |
50 |
Phosphate Buffer, pH 7.2 |
900 |
15, 30, 60, 120 and 180 |
2009/04/02 |
| Nitroglycerin |
Tablet (Sublingual) |
II (Paddle) |
50 |
Phosphate Buffer, pH 6.5 |
500 |
1, 3, 5, 8, and 10 |
2010/01/15 |
| Nitroglycerin |
Film, Transdermal (Extended Release) |
Modified USP Type V (Paddle-over-disk) |
100 |
Deionized Water at 32º C |
900 |
10, 20, 30, 45, 60, 90, 120 and 180 |
2010/04/08 |
| Nizatidine |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Norethindrone |
Tablet |
|
|
Refer to USP |
|
|
2009/10/08 |
| Norethindrone Acetate |
Tablet |
|
|
Refer to USP |
|
|
2009/08/27 |
| Nortriptyline HCl |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Nystatin |
Oral Suspension |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Nystatin |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Obeticholic Acid |
Tablet |
II (Paddle) |
75 |
0.08% polysorbate 80 in 50mM sodium phosphate dibasic buffer, pH 6.8 |
900 |
5, 10, 15, 20, 30 and 45 |
2017/11/02 |
| Octreotide Acetate |
Capsule (Delayed Release) |
II (Paddle with sinker) |
50 |
Acid stage: 0.1N HCl ; Buffer stage: pH 6.8 buffer |
Acid stage: 900; Buffer stage: 900 |
Acid stage: 120; Buffer stage: 10, 20, 30 45 and 60 |
2021/04/22 |
| Octreotide Injection |
Injectable (Extended Release) |
|
|
Develop a dissolution method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency |
|
|
2010/12/23 |
| Ofloxacin |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Olanzapine |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Olanzapine |
Tablet (Orally Disintegrating) |
|
|
Refer to USP |
|
|
2015/01/15 |
| Olanzapine Pamoate |
For Intramuscular Suspension (Extended Release) |
IV (Flow through cell), 22.6 mm cell |
Flow @ 3 mL/min |
1% SLS in pH 6.8 Phosphate Buffer |
use Open Mode |
10, 20, 30, 45, 60, 75, 90, 105, 120, 150, 180, 240, 360, 480, 600, and 720 |
2015/12/24 |
| Olanzapine; Samidorphan L-malate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2023/05/18 |
| Olaparib |
Tablet |
I (Basket) |
100 |
50 mM Phosphate Buffer, pH 6.8 |
900 |
15, 30, 45 and 60 |
2024/02/16 |
| Olmesartan Medoxomil |
Tablet |
|
|
Refer to USP |
|
|
2017/11/02 |
| Olsalazine Sodium |
Capsule |
I (Basket) |
100 |
Phosphate Buffer, pH 7.5 |
900 |
10, 20, 30 and 45 |
2004/02/12 |
| Olutasidenib |
Capsule |
II (Paddle) with sinkers |
65 |
McIlvaine Buffer, pH 2.2 W/ 1.25% SDS |
500 |
10, 15, 30, 45, and 60 |
2024/02/05 |
| Omaveloxolone |
Capsule |
I (Basket) |
100 |
50 mM Sodium Phosphate Buffer, pH 6.8 |
900 |
10, 15, 20, 30, 45 and 60 |
2024/05/31 |
| Ombitasvir/ Paritaprevir/ Ritonavir and Dasabuvir Sodium |
Tablet |
II (Paddle) |
75 |
Ombitasvir, paritaprevir, ritonavir: 0.05 M sodium phosphate buffer, pH 6.8 with 0.3% polyoxyethylene 10 lauryl ether; Dasabuvir sodium: 0.05 M Sodium Phosphate buffer, pH 6.8 with 15 mM cetyl triethylammonium bromide (CTAB) |
900 |
Ombitasvir, paritaprevir, ritonavir: 10, 20, 30, 45, 60, 90, 120 and 150; Dasabuvir: 5, 10, 15, 20 and 30 |
2015/08/27 |
| Ombitasvir/Paritaprevir/Ritonavir |
Tablet |
II (Paddle) with sinker |
75 |
0.05M Sodium Phosphate Buffer, pH 6.8 with 0.3% (w/v) Polyoxyethylene 10 Lauryl Ether (POE10LE) |
900 |
10, 20, 30, 45, 60, 90, 120, 150 and 180 |
2016/06/30 |
| Omega-3-Acid Ethyl Esters |
Capsule |
|
|
Develop an in vitro release method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate pharmacopoeial apparatus, for comparative evaluation by the Agency. |
|
|
2016/03/17 |
| Omeprazole |
Capsule (Delayed Release) |
|
|
Refer to USP |
|
|
2007/06/18 |
| Omeprazole |
OTC Tablet (Delayed Release) |
II (Paddle) |
100 |
Tablets are pre-exposed to 750 ml of 0.1M HCL for 2 hrs and then 250 ml of 0.2M Na3PO4 is added to the medium to give 1000 ml with pH 6.8 |
Acid stage: 750; Buffer stage: 1000 |
Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60 |
2013/02/28 |
| Omeprazole (Orally Disintegrating) |
OTC Tablet (Delayed Release) |
II (Paddle) |
100 |
Tablets are pre-exposed to 500 ml of 0.1M HCL for 2 hrs and then 400 ml of 0.235M Na2HP04 is added to the medium. Adjust if necessary with 2 N HCI or 2 N NaOH to a pH of 6.8 |
Acid stage: 500; Buffer stage: 900 |
Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60 |
2018/02/08 |
| Omeprazole Magnesium |
Capsule, Delayed Release |
II (Paddle) |
100 |
Acid stage: 0.1 N HCl (deaerated) for 2 hrs; Buffer stage: Phosphate buffer (deaerated), pH 6.8 |
|
Acid stage: 120; Buffer stage: 10, 20, 30 and 45 |
2023/03/30 |
| Omeprazole Magnesium |
For suspension (Delayed Release) |
II (Paddle) |
100 |
Pre-exposed to 300 mL of 0.1M HCl for 2 hrs and then 700 mL of 0.086 M Na2HPO4 is added to the medium to give 1000 mL with pH 6.8 |
Acid stage: 300; Buffer stage: 1000 |
Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60 |
2019/02/07 |
| Omeprazole Magnesium |
OTC Tablet (Delayed Release) |
II (Paddle) |
100 |
Tablets are pre-exposed to 300 mL of 0.1M HCL for 2 hrs and then 700 mL of 0.086 M Na2HPO4 is added to the medium containing the capsule to give 1000 mL with pH 6.8 |
300 ml for the acid stage; 1000 ml for the buffer stage |
Sampling started at the buffer stage 10, 20, 30, 45 and 60 |
2007/01/03 |
| Omeprazole Sodium Bicarbonate |
Powder for suspension (Immediate Release) |
II (Paddle) |
50 |
0.25 mM Sodium Phosphate Buffer, pH 7.4 |
900 |
5, 10, 15, and 30 |
2007/06/20 |
| Omeprazole Sodium Bicarbonate |
Capsule |
II (Paddle) |
75 |
Phosphate Buffer, pH 7.4 |
900 |
15, 30, 45 and 60 |
2008/07/14 |
| Ondansetron |
Tablet (Orally Disintegrating) |
|
|
Refer to USP |
|
|
2007/06/18 |
| Ondansetron |
Film (Oral) |
V (Paddle over Disk) with a stainless steel disk (120 mesh screens) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20 and 30 |
2012/01/26 |
| Ondansetron HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Opicapone |
Capsule |
I (Basket with sinker) |
100 |
Tier 1: 0.05 M Phosphate Buffer, pH 6.8 with 1% cetrimide; Tier 2: Stage 1: 0.05 M Phosphate Buffer, pH 6.8 with pancreatin (1750 USP units/L); Stage 2: after 10 minutes of Stage 1, add 100 mL of 10% cetrimide. |
|
5, 10, 15, 20, 30 and 45 |
2022/05/12 |
| Orlistat |
Capsule |
II (Paddle) |
75 |
3% SLS in 0.5% Sodium Chloride, pH 6.0 |
900 |
10, 20, 30, 45 and 60 |
2004/02/12 |
| Orphenadrine Citrate |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Oseltamivir Phosphate |
Oral Suspension |
II (Paddle) |
25 |
0.1 N HCl |
900 |
5, 10, 15, 20 and 30 |
2009/07/15 |
| Oseltamivir Phosphate |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Osilodrostat Phosphate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2021/08/19 |
| Osimertinib Mesylate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Ospemifene |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Oteseconazole |
Capsule |
II (Paddle) with sinker |
75 |
Tier 1: Stage 1: 0.01N HCl; Stage 2: After 15 minutes, add 150 mL of 3.0% SLS Tier 2: Stage 1: Pepsin (750,000 units/L) in 0.01N HCl; Stage 2: After 15 minutes, add 150 mL of 3.0% SLS |
|
20, 30, 45 and 60 |
2023/10/06 |
| Oxandrolone |
Tablet |
|
|
Refer to USP |
|
|
2023/02/09 |
| Oxaprozin |
Tablet |
|
|
Refer to USP |
|
|
2016/03/17 |
| Oxazepam |
Capsule |
|
|
Refer to USP |
|
|
2024/05/31 |
| Oxcarbazepine |
Suspension |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Oxcarbazepine |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Oxcarbazepine |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Oxybutynin |
Trans-dermal |
Paddle over Disk (Apparatus 5) |
50 |
Phosphate Buffer, pH 4.5 @ 32oC |
900 |
1, 4, 24 hours |
2007/01/03 |
| Oxybutynin Chloride |
Tablet (Extended Release) |
|
|
Refer to USP |
|
|
2015/12/24 |
| Oxycodone |
Capsule (Extended Release) |
I (Basket) |
100 |
22 mM Sodium Acetate buffer, pH 4.5 with 0.03% Tween 20 |
900 |
1, 2, 4, 6, 8, 12, 16, 20 and 24 hours |
2016/07/28 |
| Oxycodone HCl |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Oxycodone HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Oxycodone HCl |
Tablet (Extended Release) |
|
|
Refer to USP |
|
|
2016/03/17 |
| Oxycodone HCl/ Naloxone HCl |
Tablet (Extended Release) |
II (Paddle) |
50 |
Simulated Gastric Fluid [SGF, pH 1.2] without enzyme |
900 |
0.25, 0.5, 1, 2, 4, 6, 8, 10 and 12 hours |
2016/12/22 |
| Oxymorphone HCl |
Tablet (Extended Release) |
II (Paddle) with sinker |
50 |
45 mM Phosphate Buffer, pH 4.5 |
900 |
1, 2, 4, 6, 8 and 10 hours |
2014/02/14 |
| Oxymorphone HCl |
Tablets |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Ozanimod HCl |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2022/05/12 |
| Pacritinib Citrate |
Capsule |
II (Paddle) with sinker |
75 |
0.08 M HCl/0.034 M NaCl, pH 1.2 |
900 |
5, 10, 15 and 30 |
2023/05/18 |
| Palbociclib |
Capsule |
II (Paddle) with sinker |
50 |
0.1 N HCl |
900 |
10, 15, 20, 30 and 45 |
2016/03/17 |
| Palbociclib |
Tablet |
II (Paddle) |
75 |
0.1 N HCl |
900 |
10, 15, 20, 30 and 45 |
2021/08/19 |
| Paliperidone |
Tablet (Extended Release) |
II (Paddle) |
50 |
Modified SGF, pH 1.0 [NaCl (0.2% w/w) in 0.0825N HCl] |
500 |
1, 2, 4, 6, 8, 12, 14, 18 and 24 hours |
2009/08/27 |
| Paliperidone Palmitate |
Intramuscular Suspension (Extended Release) |
II (Paddle) |
50 |
0.489% (w/v) Polysorbate 20 in 0.001 N HCl @25.0 °C. |
900 |
1.5, 5, 8, 10, 15, 20, 30 and 45 |
2011/09/01 |
| Paliperidone Palmitate [3-month injection] |
Intramuscular Suspension (Extended Release) |
II (Paddle) |
50 |
0.489% (w/v) Polysorbate 20 in 0.001 N HCl @25.0 °C. |
900 |
5, 30, 60, 90, 120, 180, 240, 300 and 360 |
2016/03/17 |
| Palonosetron HCl |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Palovarotene |
Capsule |
II (Paddle) with sinkers |
50 |
5 mM Phosphate buffer, pH 8.0 with 0.5% SLS |
900 |
5, 10, 15, 30, 45 and 60 |
2024/11/01 |
| Pancrelipase |
Capsule (Delayed Release) |
|
|
Refer to USP |
|
|
2016/03/17 |
| Pancrelipase |
Tablet |
II (Paddle) |
50 |
Phosphate Buffer, pH 4.5 |
900 |
10, 20, 30, 45 and 60 |
2016/06/02 |
| Panobinostat Lactate |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Pantoprazole Sodium |
Delayed Release Granules for Oral Suspension |
II (Paddle) |
100 |
Acid Stage: 0.1 N Hydrochloric Acid; Buffer Stage: 0.05 M Tribasic Sodium Phosphate (Add 250 mL of 0.2 mM Tribasic Sodium Phosphate after completion of acid stage); pH 6.8 (Method B) |
Acid stage: 750; Buffer stage: 1000 |
Acid stage: 60, 90 and 120; Buffer stage: 10, 20, 30, 45 and 60 |
2009/10/30 |
| Pantoprazole Sodium |
Tablet (Delayed Release) |
|
|
Refer to USP |
|
|
2009/07/21 |
| Paricalcitol |
Capsule |
I (Basket) |
100 |
4 mg/mL (0.4%) Lauryldimethylamine N-oxide (LDAO) |
500 |
20, 30, 45, 60 |
2007/06/18 |
| Paromomycin Sulfate |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Paroxetine |
Tablet (Extended Release) |
|
|
Refer to USP |
|
|
2015/11/19 |
| Paroxetine HCl |
Suspension |
II (Paddle) |
100 |
SGF without enzyme |
900 |
10, 20, 30 and 45 |
2004/02/13 |
| Paroxetine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Paroxetine Mesylate |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Paroxetine Mesylate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Patisiran Sodium |
Solution |
II (Paddle) |
25 |
Tris/EDTA buffer, pH 7.5 with 0.02% Tween 20 |
500 |
2, 5, 7, 11 and 15 |
2023/03/30 |
| Pazopanib HCl |
Tablet |
II (Paddle) |
75 |
50 mM Sodium Acetate buffer, pH 4.5, containing 0.75% SDS |
900 |
10, 15, 30, 45 and 60 |
2010/08/05 |
| Pemigatinib |
Tablet |
I (Basket) |
50 |
0.01 N HCl |
500 |
5, 10, 15, 20, 30 and 45 |
2022/05/12 |
| Pemoline |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Penbutolol Sulfate |
Tablet |
|
|
Refer to USP |
|
|
2010/06/24 |
| Penicillamine |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Penicillin G Benzathine |
Injectable |
|
|
Develop a method to characterize in vitro release |
|
|
2021/08/19 |
| Penicillin V |
Tablet |
|
|
Refer to USP |
|
|
2011/06/09 |
| Penicillin V Potassium |
Tablet |
|
|
Refer to USP |
|
|
2011/06/09 |
| Pentosan Polysulfate Sodium |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Pentoxifylline |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Perampanel |
Suspension |
II (Paddle) |
50 |
0.1 N HCl |
900 [890 mL 0.1 N HCl + 10 mL perampanel suspension] |
5, 10, 15, 20 and 30 |
2016/12/22 |
| Perampanel |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20 and 30 |
2014/05/15 |
| Pergolide Mesylate |
Tablet |
II (Paddle) |
50 |
Simulated gastric fluid TS with cysteine without enzymes |
500 |
10, 20, 30 and 45 |
2006/03/04 |
| Perindopril Erbumine |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 20 , 30 and 45 |
2007/06/20 |
| Perphenazine |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Phendimetrazine Tartrate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Phendimetrazine Tartrate |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Phendimetrazine Tartrate |
Capsule (Extended Release) |
II (Paddle) |
50 |
1 hour - SGF w/o Enzymes; after 1 hour - SIF w/o Enzymes |
900 |
1, 2, 4, 6 and 8 hours |
2009/06/10 |
| Phenelzine Sulfate |
Tablet |
II (Paddle) |
50 |
Simulated Gastric Fluid without enzymes, pH 1.2 |
900 |
10, 20, 30 and 45 |
2010/03/25 |
| Phenoxybenzamine HCl |
Capsule |
|
|
Refer to USP |
|
|
2008/04/10 |
| Phentermine HCl |
Tablet (Orally Disintegrating) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Phentermine HCl |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Phentermine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Phentermine HCl/Topiramate |
Capsule (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Phenytoin |
Suspension |
|
|
Refer to USP |
|
|
2007/06/18 |
| Phenytoin |
Tablet (Chewable) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Phenytoin Sodium |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Phytonadione |
Tablet |
|
|
Develop a dissolution method |
|
|
2010/03/25 |
| Pilocarpine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Pimavanserin Tartrate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Pimozide |
Tablet |
|
|
Refer to USP |
|
|
2008/02/19 |
| Pindolol |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Pioglitazone HCl |
Tablet |
II (Paddle) |
75 |
HCl-0.3 M KCl Buffer, pH 2.0 |
900 |
5, 10, 15 and 30 |
2004/02/13 |
| Pirfenidone |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Pirfenidone |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Piroxicam |
Capsule |
|
|
Refer to USP |
|
|
2012/10/04 |
| Pirtobrutinib |
Tablet |
II (Paddle) |
75 |
Sodium Phosphate Buffer, pH 6.8 |
900 |
5, 10, 15, 20, 30, 45 and 60 |
2024/05/31 |
| Pitavastatin Calcium |
Tablet |
I (Basket) |
35 |
0.05 M Phosphate Buffer, pH 6.8 |
900 |
5, 10, 15, 20, 30 and 45 |
2010/12/23 |
| Pomalidomide |
Capsule |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 15, 20, 30 and 45 |
2015/05/28 |
| Ponatinib HCl |
Tablet |
I (Basket) |
50 |
pH 2.1, KCl/HCl buffer (degassed) |
900 |
10, 15, 20, 30, 45 and 60 |
2015/09/03 |
| Posaconazole |
Tablet (Delayed Release) |
II (Paddle) |
75 |
Acid Stage: 0.01 N HCl: Buffer Stage: 50 mM phosphate buffer, pH 6.8 with 0.37 % Polysorbate 80 (after 120 minutes, to the acid stage, add 250 mL of 0.2M Phosphate Buffer, 1.46% Polysorbate 80) |
Acid Stage: 750 mL; Buffer Stage 1000 mL |
Acid Stage: 120; Buffer Stage: 10, 15, 20, 30 and 45 |
2015/06/25 |
| Posaconazole |
For Suspension (Delayed Release) |
II (Paddle) |
75 |
Acid stage: 0.01 N HCl; Buffer stage: pH 6.8 Phosphate buffer with 1.3% Tween 80; |
Acid stage: 750 mL; Buffer stage: 1000 mL |
Acid stage: 120; Buffer stage: 5, 10, 15, 20, 30 and 45 |
2022/07/07 |
| Posaconazole |
Oral Suspension |
II (Paddle) |
25 |
0.3% SLS |
900 |
10, 20, 30 and 45 |
2007/12/03 |
| Potassium Chloride |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Potassium Chloride |
Capsule (Extended Release) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Potassium Citrate |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Pralsetinib |
Capsule |
II (Paddle) with sinker |
50 |
50 mM Sodium Phosphate Buffer, pH 6.8, with 0.4% w/v Cetyl Trimethylammonium Bromide (CTAB) |
900 |
10, 20, 30, 45 and 60 |
2022/07/07 |
| Pramipexole Dihydrochloride |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Pramipexole Dihydrochloride |
Tablet (Extended Release) |
I (Basket) |
100 |
0.05 M phosphate buffer, pH 6.8 |
500 |
1, 2, 4, 6, 9, 12, 16, 20 and 24 hours |
2010/09/02 |
| Prasugrel HCl |
Tablet |
II (Paddle) |
75 |
Citrate-Phosphate buffer (0.023M Citric acid+0.026M Sodium Phosphate, Dibasic), pH 4.0 |
900 |
10, 15, 20, 30 and 45 |
2012/10/04 |
| Pravastatin Sodium |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Praziquantel |
Tablet |
|
|
Refer to USP |
|
|
2015/06/25 |
| Prazosin HCl |
Capsule |
|
|
Refer to USP |
|
|
2022/05/12 |
| Prednisolone |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Prednisolone Acetate |
Ophthalmic Suspension |
|
|
Develop an in vitro release method |
|
|
2014/05/15 |
| Prednisolone Sodium Phosphate |
Tablet (Orally Disintegrating) |
II (Paddle) |
50 |
22 mM Sodium Acetate Buffer, pH 4.5 |
500 |
5, 15, 30, 45 and 60 |
2008/09/03 |
| Prednisone |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Prednisone |
Tablet (Delayed Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Pregabalin |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Pregabalin |
Tablet (Extended Release) |
II (Paddle) |
50 |
0.06 M HCl |
900 |
1, 2, 4, 6, 8, 10, 12, 16 and 24 hours |
2018/02/08 |
| Pretomanid |
Tablet |
II (Paddle) |
75 |
0.1 N HCl with 0.5% hexadecyltrimethylammonium (HDTMA) |
1000 |
5, 10, 15, 20, 30 and 45 |
2021/04/22 |
| Primaquine Phosphate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Primidone |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/11/30 |
| Primidone |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Procarbazine HCl |
Capsules |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Prochlorperazine |
Rectal Suppository |
I (Suppository, dissolution baskets, palmieri type) |
100 |
0.1 N HCl at 38° C |
900 |
10, 20, 30 and 45 |
2006/08/17 |
| Prochlorperazine Maleate |
Tablet |
II (Paddle) |
75 |
0.1 N HCl |
500 |
10, 20, 30, 45, 60, 75, and 90 |
2021/04/22 |
| Progesterone |
Gel |
I (Basket) with Diacell sample holder |
100 |
Methanol:water 20:80 |
1000 |
2, 4, 8, 12, 20, 24, 48 and 72 hours |
2023/03/30 |
| Progesterone |
Vaginal Insert |
II (Paddle) |
50 |
0.25% sodium dodecyl sulfate (SDS) in DI water |
900 |
5, 10, 15, 20 and 30 |
2012/10/04 |
| Progesterone |
Capsule |
|
|
Develop a quantitative rupture test |
|
|
2010/04/08 |
| Promethazine HCl |
Rectal Suppository |
|
|
Develop a method to characterize in vitro release |
|
|
2016/10/20 |
| Promethazine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Propafenone HCl |
Tablet |
|
|
Refer to USP |
|
|
2017/11/02 |
| Propafenone HCl |
Capsule (Extended Release) |
|
|
Refer to USP |
|
|
2017/11/02 |
| Propranolol HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2021/04/22 |
| Propranolol HCl |
Capsule (Extended Release) |
|
|
Refer to USP |
|
|
2007/07/25 |
| Propylthiouracil |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Protriptyline HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Protriptyline HCl |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Prucalopride Succinate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2021/04/22 |
| Pseudoephedrine HCl |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Pseudoephedrine HCl/Triprolidine HCl |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Pyrazinamide |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Pyridostigmine Bromide |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Pyridostigmine Bromide |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Pyrimethamine |
Tablet |
|
|
Refer to USP |
|
|
2015/06/25 |
| Quetiapine Fumarate |
Tablet (Extended Release) |
I (Basket, with 20 mesh) |
200 |
0.05M citric acid and 0.09 N NaOH (pH 4.8) [solution A]. At 5 hrs, pH adjusted to 6.6 by addition of 100 mL of 0.05M dibasic sodium phosphate and 0.46N NaOH [solution B] |
900 [solution A]. 1000 [final] |
1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 hours |
2013/01/31 |
| Quetiapine Fumarate |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Quinapril HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Quinidine Gluconate |
Tablet (Extended Release) |
|
|
Refer to USP |
|
|
2021/04/22 |
| Quinine Sulfate |
Capsule |
|
|
Refer to USP |
|
|
2008/01/14 |
| Quizartinib Dihydrochloride |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
15, 20, 30, 45, and 60 |
2024/11/01 |
| Rabeprazole Sodium |
Capsule (Delayed Release) |
II (Paddle) |
Acid Stage: 75 rpm; Buffer Stage: 60 rpm |
Acid Stage:0.1 N HCl; Buffer Stage: 0.05 M Phosphate Buffer, pH 6.8 (After Acid Stage, add 250 mL of 0.2 mol/L trisodium phosphate solution). |
Acid Stage: 750; Buffer Stage:1000 |
Acid Stage: 120; Buffer Stage: 10, 15, 20, 25, 30 and 45 |
2014/05/15 |
| Rabeprazole Sodium |
Tablet (Delayed Release) |
II (Paddle) |
100 |
700 mL 0.1 N HCl (Acid stage), after two hours add 300 mL of 0.6 M Tris buffer; adjust to pH 8.0 (Buffer stage) with 2 N HCl or 2 N NaOH . Stabilize the samples with the addition of 0.5 N NaOH |
Acid stage: 700; Buffer stage: 1000 |
Acid stage: 120; Buffer stage: 10, 20, 30, and 45 |
2011/09/22 |
| Raloxifene HCl |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Raltegravir Potassium |
Tablet (Chewable) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Raltegravir Potassium |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Ramelteon |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Ramipril |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Ramipril |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Ranitidine HCl |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Ranitidine HCl |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Ranitidine HCl |
Tablet (Effervescent) |
|
|
Develop a dissolution method |
|
|
2010/04/08 |
| Ranolazine |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2019/02/07 |
| Ranolazine |
Granules (Extended Release) |
II (Paddle) |
50 |
0.1 N HCl |
900 |
0.5, 1, 2, 3, 4, 6 and 8 hours |
2022/07/07 |
| Rasagiline Mesylate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Regorafenib |
Tablet |
II (Paddle) |
75 |
Acetate Buffer pH 4.5 with 0.1% Sodium Dodecyl Sulfate (SDS) |
900 |
10, 15, 20, 30 and 45 |
2015/06/25 |
| Relugolix |
Tablet |
II (Paddle) |
50 |
50 mM Citrate Buffer, pH 5.5 |
900 |
5, 10, 15, 20 and 30 |
2022/07/07 |
| Repaglinide |
Tablet |
|
|
Refer to USP |
|
|
2007/07/25 |
| Resmetirom |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/09/03 |
| Ribavirin |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Ribavirin |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Ribociclib |
Tablet |
II (Paddle) |
50 |
0.01N HCl (degassed) |
900 |
10, 20, 30, 45 and 60 |
2022/05/12 |
| Rifabutin |
Capsule |
|
|
Refer to USP |
|
|
2009/12/15 |
| Rifampin |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Rifamycin Sodium |
Tablet (Delayed Release) |
II (Paddle) |
100 |
Acid stage: HCl 0.1 N with 0.5% w/v Macrogol Cetostearyl Ether; Buffer stage: pH 7.2 Sodium Phosphate buffer |
|
Acid Stage: 2 hours; Buffer Stage: 1, 2, 3 and 4 hours |
2021/04/22 |
| Rifapentine |
Tablet |
II (Paddle) |
50 |
0.8% SLS in Phosphate Buffer, pH 7.0 |
900 |
10, 20, 30, 45, 60 and 90 |
2004/02/25 |
| Rifaximin (200 mg) |
Tablet |
II (Paddle) |
75 |
0.1M sodium phosphate buffer pH 7.4 containing 0.45% Sodium Lauryl Sulfate |
1000 |
10, 20, 30, 45, 60, 90 and 120 |
2011/07/21 |
| Rifaximin (550 mg) |
Tablet |
II (Paddle) |
75 |
0.1M sodium phosphate buffer pH 7.4 containing 0.8% Sodium Lauryl Sulfate |
1000 |
10, 20, 30, 45, 60, 90 and 120 |
2011/07/21 |
| Rilpivirine HCl |
Tablet |
II (Paddle) |
75 |
0.5% Polysorbate 20 in 0.01N HCl (pH=2.0) |
900 |
10, 20, 30, 45 and 60 |
2013/08/15 |
| Riluzole |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 20, 30, 45 and 60 |
2004/02/18 |
| Riluzole |
Suspension |
II (Paddle) |
35 |
Phosphate Buffer pH 4.5 |
900 [890 mL of medium + 10 mL of suspension] |
5, 10, 20, 30, 45 and 60 |
2022/05/12 |
| Rimantadine HCl |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Rimegepant Sulfate |
Tablet, (Orally Disintegrating (ODT)) |
II (Paddle) |
50 |
50 mM Sodium Acetate Buffer, pH 4.5 |
500 |
5, 10, 15, 20 and 30 |
2022/05/12 |
| Rimexolone |
Ophthalmic Suspension |
|
|
Develop a method to characterize in vitro release |
|
|
2016/06/30 |
| Riociguat |
Tablet |
II (Paddle) |
75 |
pH 6.8 Phosphate Buffer with 0.1% Sodium Lauryl Sulfate [SLS] |
900 |
5, 10, 15, 20 and 30 |
2015/12/24 |
| Ripretinib |
Tablet |
II (Paddle) |
75 |
10 mM Sodium Acetate Buffer, pH 4.5, containing 0.25% (w/v) sodium dodecyl sulfate (SDS) |
900 |
5, 10, 15, 20, 30 and 45 |
2022/05/12 |
| Risedronate Sodium |
Tablet (Delayed Release) |
II (Paddle) |
75 |
Acid stage: 0.1 N HCl; Buffer stage: Phosphate buffer, pH 6.8 |
Acid stage: 500; Buffer stage: 500 |
Acid stage: 120; Buffer Stage: 10, 15, 20, 30 and 45 |
2012/01/26 |
| Risedronate Sodium |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Risedronate Sodium/Calcium Carbonate |
Tablet (Copackaged) |
|
|
For Risedronate Tablets: Refer to USP; For Calcium Carbonate Tablets: Refer to USP. |
|
|
2010/07/01 |
| Risperidone |
For Suspension (Extended Release) |
|
|
Develop a dissolution method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency |
|
|
2010/01/15 |
| Risperidone |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
500 |
10, 20, 30, 45 and 60 |
2006/03/04 |
| Risperidone |
Tablet (Orally Disintegrating) |
II (Paddle) |
50 |
0.1 N HCl |
500 |
5, 10, 15 |
2004/07/23 |
| Ritlecitinib Tosylate |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2024/11/01 |
| Ritonavir |
Powder |
I (Basket -100 mesh) |
100 |
0.1 N HCl |
900 |
5, 10, 15, 20 and 30 |
2017/11/16 |
| Ritonavir |
Tablet |
|
|
Refer to USP |
|
|
2015/01/15 |
| Ritonavir |
Capsule |
|
|
Refer to USP |
|
|
2015/01/15 |
| Rivaroxaban (10 mg) |
Tablet |
II (Paddle) |
75 |
Acetate Buffer pH 4.5, 0.2% sodium dodecyl sulfate (SDS) |
900 |
10, 15, 20, 30 and 45 |
2015/01/15 |
| Rivaroxaban (15 and 20 mg) |
Tablet |
II (Paddle) |
75 |
Acetate Buffer pH 4.5, 0.4% SDS |
900 |
10, 15, 20, 30 and 45 |
2015/01/15 |
| Rivaroxaban (2.5 mg) |
Tablet |
II (Paddle) |
75 |
Acetate Buffer pH 4.5 |
900 |
10, 15, 20, 30 and 45 |
2019/02/07 |
| Rivastigmine |
Film, Transdermal |
Modified USP Type VI (cylinder) |
50 |
0. 9 % NaCl at 32º C |
500 |
1, 2, 4, 7, 9 and 12 hours |
2009/06/10 |
| Rivastigmine Tartrate |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Rizatriptan Benzoate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Rizatriptan Benzoate |
Tablet, (Orally Disintegrating (ODT)) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Roflumilast |
Tablet |
II (Paddle) |
50 |
1.0% SDS (sodium dodecyl sulfate) in Phosphate Buffer, pH 6.8 |
1000 |
5, 10, 15, 20, 30 and 45 |
2013/08/15 |
| Rolapitant HCl |
Tablet |
II (Paddle) |
50 |
0.05 M Sodium Acetate buffer, pH 4.0 |
900 |
10, 15, 20, 30 and 45 |
2016/10/20 |
| Ropinirole HCl |
Tablet |
|
|
Refer to USP |
|
|
2014/05/15 |
| Ropinirole HCl |
Tablet (Extended Release) |
II (Paddle) |
100 |
pH 4.0 Citrate-THAM Buffer |
500 |
1, 2, 4, 6, 8, 12, 16, 20 and 24 hours |
2009/08/27 |
| Rosuvastatin Calcium |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Rotigotine |
Transdermal |
Paddle over Disk (Apparatus 5) |
50 |
Phosphate Buffer, pH 4.5 at 32°C |
900 |
15, 30, 60, 90, 120, 150 and 180 |
2009/07/15 |
| Rucaparib |
Tablet |
II (Paddle) |
75 |
0.01 N HCl |
900 |
5, 10, 15, 20 and 30 |
2017/01/19 |
| Rufinamide |
Tablet |
|
|
Refer to USP |
|
|
2013/08/15 |
| Rufinamide |
Suspension |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Ruxolitinib Phosphate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Sacubitril/Valsartan |
Tablet |
I (Basket) |
75 |
Phosphate Buffer, pH 6.8[degassed] |
900 |
10, 15, 20, 30 and 45 |
2019/10/24 |
| Safinamide Mesylate |
Tablet |
II (Paddle) |
100 |
0.1 N HCL with Sodium Chloride [0.2% (wt/vol) solution], pH 1.2 |
900 |
5, 10, 15, 30, 45 and 60 |
2023/10/06 |
| Sapropterin Dihydrochloride |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Saquinavir Mesylate |
Tablet |
II (Paddle) |
50 |
Citrate Buffer (pH 3.0) |
900 |
10, 20 , 30 and 45 |
2007/09/13 |
| Saquinavir Mesylate |
Capsule |
|
|
Refer to USP |
|
|
2007/09/13 |
| Saxagliptin HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Scopolamine |
Transdermal |
Reciprocating disk (Apparatus 7) |
Stroke depth: 2-3 cm; 30-60 cycles per minute |
Distilled Water |
25 × 150 mm test-tubes containing 20 mL |
1, 2, 4, 6, 12, 18, 24, 36, 48, and 72 hours |
2009/07/15 |
| Secnidazole |
Granule |
I (Basket) |
50 |
Phosphate Buffer, pH 6.8 |
900 |
0.5, 1, 1.5, 2, 2.5, 3, 3.5 and 4 hours |
2017/11/16 |
| Selegiline HCl |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Selegiline (20 mg/20 cm2 and 30 mg/30 cm2) |
Transdermal |
Paddle over Disk (Apparatus 5) |
50 |
0.1 M Phosphate buffer, monobasic, pH 5 at 32°C |
500 |
1, 2, 4, 8, 12, 16, 20 and 24 hours |
2009/07/15 |
| Selegiline (40 mg/40 cm2) |
Transdermal |
Rotating Cylinder (Apparatus 6) |
50 |
0.1 M Phosphate buffer, monobasic, pH 5 at 32°C |
1000 |
1, 2, 4, 8, 12, 16, 20 and 24 hours |
2009/07/15 |
| Selegiline HCl |
Tablet (Orally Disintegrating) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Selexipag |
Tablet |
II (Paddle) |
50 |
Phosphate Buffer, pH 6.8 |
900 |
5, 10, 15, 20 and 30 |
2016/03/17 |
| Selinexor |
Tablet |
II (Paddle) |
75 |
10 mM Citric Acid Buffer, pH 4.5 with 0.5% SDS |
900 |
10, 15, 20, 30 and 45 |
2021/08/19 |
| Selpercatinib |
Capsule |
II (Paddle) |
75 |
0.1N HCl |
900 |
5, 10, 15, 20 and 30 |
2022/07/07 |
| Selumetinib |
Capsule |
II (Paddle) with sinker |
75 |
Sodium Phosphate Buffer, pH 6.5, with 0.5% Polysorbate 80 |
1000 |
10, 20, 30, 45 and 60 |
2022/07/07 |
| Semaglutide |
Tablet |
II (Paddle) |
70 |
50 mM Phosphate Buffer with 0.05% Brij 35 (polyoxyethylene lauryl ether), pH 6.8 |
500 |
10, 15, 20, 30, 45, 60 and 75 |
2021/08/19 |
| Sertraline HCl |
Capsule |
II (Paddle) with sinker |
75 |
0.1 N HCl |
900 |
10, 15, 20, 30 and 45 |
2023/07/07 |
| Sertraline HCl |
Tablet |
II (Paddle) |
75 |
0.05 M Sodium Acetate Buffer, pH 4.5 |
900 |
10, 20, 30 and 45 |
2004/02/20 |
| Sevelamer Carbonate |
Tablet |
|
|
Disintegration Testing in 0.1 N HCl as per USP <701> |
|
|
2008/10/06 |
| Sevelamer HCl |
Capsule |
|
|
Disintegration Testing in 0.1 N HCl as per USP <701> |
|
|
2008/04/09 |
| Sevelamer HCl |
Tablet |
|
|
Disintegration Testing in 0.1 N HCl as per USP <701> |
|
|
2008/04/09 |
| Sibutramine HCl |
Capsule |
II (Paddle) |
50 |
0.05 M Acetate Buffer, pH 4.0 |
500 |
10, 20, 30, 45 and 60 |
2004/02/25 |
| Sildenafil Citrate |
Tablet |
I (Basket) |
100 |
0.01 N HCl |
900 |
5, 10, 15 and 30 |
2006/03/04 |
| Sildenafil Citrate |
Suspension |
II (Paddle) |
50 |
McIlvaine Buffer, pH 5.0 |
500 |
5, 10, 15, 20 and 30 |
2015/05/28 |
| Silodosin |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Simeprevir Sodium |
Capsule |
II (Paddle) |
75 |
0.05 M Phosphate Buffer, pH 6.8 with 1.0% polysorbate 20 |
900 |
10, 15, 20, 30 and 45 |
2015/05/28 |
| Simvastatin |
Suspension |
II (Paddle) |
50 |
Phosphate Buffer, pH 7.0, with 0.14% sodium dodecyl sulfate (SDS) |
900 |
10, 15, 20, 30 and 45 |
2016/12/22 |
| Simvastatin |
Tablet |
|
|
Refer to USP |
|
|
2007/06/18 |
| Simvastatin |
Tablet (Orally Disintegrating) |
II (Paddle) |
75 |
0.15% SDS Buffer, pH 6.8 |
900 |
5, 10, 15 and 30 |
2008/09/03 |
| Siponimod Fumaric Acid |
Tablet |
II (Paddle) |
50 |
Phosphate Buffer, pH 6.8 with 0.1% (m/v) Polysorbate 80 |
900 mL [for 2 mg strength]
500 mL [for 0.25 mg strength] |
5, 10, 15, 20 and 30 |
2021/08/19 |
| Sirolimus |
Gel |
|
|
Develop a method to characterize in vitro release |
|
|
2023/05/18 |
| Sirolimus |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Sitagliptin Phosphate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Sitagliptin Phosphate/Simvastatin |
Tablet |
II (Paddle) with stainless steel stationary quadrangular hanging basket |
100 |
10 mM Sodium phosphate buffer containing 1% Tween 80 with 50 μg/mL Butylated hydroxyanisole |
900 |
5, 10, 15, 20, 30, and 45 |
2013/10/31 |
| Sodium Iodide I-123 |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Sodium Iodide I-131 |
Capsule |
|
|
Develop a dissolution method |
|
|
2022/07/07 |
| Sodium Oxybate |
For Suspension (Extended Release) |
II (Paddle) |
100 |
Stage 1: 0.1N HCl for 2h; Stage 2: pH 6.0 Phosphate Buffer for 6h |
900 |
0.25, 1, 2, 2.5, 3, 3.5, 4 and 5 hours |
2024/05/31 |
| Sodium Phenylbutyrate |
Pellets |
II (Paddle) |
75 |
Simulated Intestinal Fluid without pancreatin |
900 |
5, 10, 15, 30 and 45 |
2024/02/05 |
| Sodium Phenylbutyrate |
Powder for Oral |
II (Paddle) |
75 |
Simulated Intestinal Fluid |
900 |
15, 30, 45, 60 and 90 |
2009/04/02 |
| Sodium Phenylbutyrate; Taurursodiol |
Powder |
II (Paddle) |
75 |
5 mM phosphate w/ 0.1% SDS, pH 6.8 |
900 |
5, 10, 15, 30 and 45 |
2024/02/05 |
| Sodium Phosphate Dibasic Anhydrous/Sodium Phosphate Monobasic Monohydrate |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Sofosbuvir |
Pellets |
II (Paddle) |
75 |
25 mM Potassium Phosphate Buffer, pH 5.5 |
900 |
5, 10, 15, 20, 30 and 45 |
2021/08/19 |
| Sofosbuvir |
Tablet |
II (Paddle) |
75 |
0.05 M Phosphate Buffer, pH 6.8 |
900 |
5, 10, 15, 20 and 30 |
2021/08/19 |
| Sofosbuvir/Velpatasvir |
Tablet |
II (Paddle) |
75 |
50 mM sodium acetate buffer,pH 5.0, with 0.5% w/v Cetyltrimethyl ammonium bromide (CTAB) |
900 |
5, 10, 15, 20 and 30 |
2016/10/20 |
| Solifenacin Succinate |
Suspension |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20 and 30 |
2022/07/07 |
| Solifenacin Succinate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Solriamfetol HCl |
Tablet |
I (Basket) |
100 |
0.1 N HCl |
900 |
5, 10, 15, 20 and 30 |
2021/08/19 |
| Sonidegib Phosphate |
Capsule |
II (Paddle) with sinker |
75 |
Tier 1: 0.1 M HCl with 1.0% SDS; Tier II: Stage 1: 850 mL of 0.1 N HCl solution with pepsin [250’000 units/L]. Stage 2: After 10 minutes add 50 mL of 18% SDS in 0.1 N HCl |
Tier 1: 900; Tier 2: Stage 1: 850 mL, Stage 2: 900 mL |
15, 30, 45, 60, and 90 |
2016/03/17 |
| Sorafenib Tosylate |
Tablet |
II (Paddle) |
75 |
0.1 M HCl with 1% SDS |
900 |
5, 10, 15, 20 and 30 |
2009/06/10 |
| Sotagliflozin |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/08/05 |
| Sotorasib |
Tablet |
II (Paddle) |
75 |
120 mg: 50 mM phosphate buffer, pH 6.8 with 0.2% SLS;
320 mg: 50 mM phosphate buffer, pH 6.8 with 0.4% SDS |
900 |
5,10,15, 20 and 30 |
2023/11/30 |
| Sparsentan |
Tablet |
II (Paddle) |
60 |
0.1 N HCl |
1000 |
5, 10, 15, 20, 30, 45 and 60 |
2024/05/31 |
| Spironolactone |
Tablet |
|
|
Refer to USP |
|
|
2008/04/15 |
| Stavudine |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Succimer |
Capsule |
II (Paddle) |
50 |
0.01 N Phosphoric Acid |
900 |
10, 20, 30, 45, 60 and 90 |
2004/02/20 |
| Sucralfate |
Suspension |
II (Paddle) |
75 |
0.1N HCl/0.067 M KCl, pH 1.0 |
900 |
10, 20, 30 and 45 |
2006/03/04 |
| Sucralfate |
Tablet |
II (Paddle) |
75 |
0.1 N HCl/0.067 M KCl, pH 1.0 |
900 |
15, 30, 45, 60, 180, 240 and 480 |
2009/04/02 |
| Sucroferric Oxyhydroxide |
Tablet (Chewable) |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 15, 20, 30, 45 and 60 |
2017/11/02 |
| Sufentanil Citrate |
Tablet (Sublingual) |
II (Paddle) |
50 |
pH 4.5 Acetate Buffer |
50 |
2, 4, 8, 12 and 15 |
2022/05/12 |
| Sulfadiazine |
Tablet |
|
|
Refer to USP |
|
|
2008/07/14 |
| Sulfamethoxazole/Trimethoprim |
Tablet |
|
|
Refer to USP |
|
|
2008/01/14 |
| Sulfamethoxazole/Trimethoprim |
Suspension |
II (Paddle) |
50 |
1 mL of 0.2 N HCl in water |
900 |
10, 20, 30, 45, 60 and 90 |
2004/02/25 |
| Sulfasalazine |
Tablet |
|
|
Refer to USP |
|
|
2009/12/15 |
| Sulfasalazine |
Tablet (Delayed Release) |
|
|
Refer to USP |
|
|
2009/12/15 |
| Sulfisoxazole Acetyl |
Oral Suspension (Pediatric) |
II (Paddle) |
30 |
1% SLS in 0.1N HCl |
900 |
15, 30, 45, 60 and 90 |
2006/08/17 |
| Sumatriptan Succinate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Sunitinib Malate |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Suvorexant |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Tacrolimus |
Capsule |
II (Paddle) |
50 |
Hydroxypropyl Cellulose Solution (1 in 20,000). Adjust to pH 4.5 by Phosphoric Acid |
900 |
30, 60, 90 and 120 |
2004/02/20 |
| Tacrolimus |
For Suspension |
II (Paddle) |
50 |
Hydroxypropyl Cellulose Solution (1 in 20,000). Adjust to pH 4.5 by Phosphoric Acid |
|
15, 30, 45, 60, 90 and 120 |
2023/02/09 |
| Tacrolimus |
Tablet (Extended Release) |
II (Paddle) |
100 |
0.005% HPC in Water with 0.50% SLS adjusted to pH 4.5 |
900 |
0.5, 1, 2.5, 4.5, 6.5, 8.5 and 12 hours |
2016/06/30 |
| Tadalafil |
Tablet |
II (Paddle) |
50 |
0.5% Sodium Lauryl Sulfate |
1000 |
10, 20, 30 and 45 |
2006/01/26 |
| Tafamidis |
Capsule |
II (Paddle) with sinker |
75 |
Tier 1 Medium: 0.05M Sodium Phosphate Buffer, pH 6.8 with 1.0% Tween 80; Tier II Medium: 0.05M Sodium Phosphate Buffer, pH 6.8 with 1.0% Tween 80 and enzyme with protease activity as per USP |
900 |
5, 10, 15, 20, 30 and 45 |
2021/04/22 |
| Tafamidis Meglumine |
Capsule |
II (Paddle) with sinker |
75 |
Tier 1 Medium: 0.05M Sodium Phosphate Buffer, pH 6.8. Tier 2 Medium: 0.05M Sodium Phosphate Buffer, pH 6.8, and pancreatin with protease activity as per USP |
900 |
5, 10, 15, 20, 30 and 45 |
2021/04/22 |
| Tafenoquine Succinate |
Tablet |
II (Paddle) |
75 |
0.01M Sodium phosphate buffer, pH 6.8, with 0.20% w/v of Polysorbate 20 |
900 |
5, 10, 20, 30, 45 and 60 |
2020/08/27 |
| Talazoparib Tosylate |
Capsule |
II (Paddle) with sinker |
75 |
0.01 N HCl with 0.2% sodium dodecyl sulfate (SDS), |
500 |
10, 15, 20, 30 and 45 |
2020/08/27 |
| Tamoxifen Citrate |
Tablet |
|
|
Refer to USP |
|
|
2009/04/02 |
| Tamsulosin HCl |
Capsule |
II (Paddle) |
100 |
0-2 hours: 0.003% polysorbate 80, pH 1.2 2-8 hours: phosphate buffer, pH 7.2 |
500 |
1, 2, 3, 6, 8, and 10 hours |
2007/03/26 |
| Tapentadol HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Tapentadol HCl |
Tablet (Extended Release) |
II (Paddle) with sinker |
100 |
0.05 M Phosphate Buffer of pH 6.8, Simulated intestinal fluid (without enzyme) |
900 |
0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours |
2013/10/31 |
| Tasimelteon |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Tasimelteon |
Suspension |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2024/05/31 |
| Tazemetostat Hydrobromide |
Tablet |
II (Paddle) |
50 |
0.01 N HCl |
900 |
5, 10, 15, 20, 30 and 45 |
2022/05/12 |
| Tedizolid Phosphate |
Tablet |
II (Paddle) |
60 |
0.05 M phosphate buffer pH 6.8 |
900 |
5, 10, 15, 20 and 30 |
2016/06/02 |
| Tegaserod Maleate |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Telaprevir |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Telbivudine |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
15, 30 and 45 |
2009/04/02 |
| Telithromycin |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 20, 30 and 45 |
2007/01/03 |
| Telmisartan |
Tablet |
|
|
Refer to USP |
|
|
2012/01/05 |
| Temazepam |
Capsule |
|
|
Refer to USP |
|
|
2008/01/14 |
| Temozolomide |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Tenapanor Hydrochloride |
Tablet |
II (Paddle) |
75 |
9.4 mM Citrate Buffer, pH 4 |
900 |
5, 10, 15, 20, 30 and 45 |
2021/08/19 |
| Tenofovir Alafenamide Fumarate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Tenofovir Disoproxil Fumarate |
Powder for Oral |
II (Paddle) |
100 |
0.2% polysorbate 80 in 0.01 M HCl |
900 |
10, 20, 30, 45, 60 and 75 |
2013/01/31 |
| Tenofovir Disoproxil Fumarate |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 20, 30, and 45 |
2007/01/03 |
| Tepotinib HCl |
Tablet |
II (Paddle) |
50 |
Acetate buffer, pH 4.5 + 1 mM NaCl + 0.1% polysorbate 80 |
900 |
5, 15, 20 and 35 |
2023/03/30 |
| Terazosin HCl |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Terazosin HCl |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Terbinafine HCl |
Tablet |
II (Paddle) |
50 |
Citrate Buffer, pH 3.0 adjusted with HCl |
500 |
10, 20, 30 and 45 |
2004/02/20 |
| Terconazole |
Suppository (Vaginal) |
I (with Palmieri type basket) |
100 |
0.12 N HCl with 1% SLS |
900 |
15, 30, 45, 60, 90, 120 and 150 |
2009/10/08 |
| Teriflunomide |
Tablet |
II (Paddle) |
50 |
0.05 M Phosphate Buffer, pH 6.8 |
1000 |
5, 10, 15, 20, 30 and 45 |
2014/05/15 |
| Testosterone |
Film, Transdermal (Extended Release) |
V (Paddle over disk). Paddle 25 mm above the film on the disk. |
50 |
0.1 M sodium chloride containing 2.5% (v/v) of Tween 40 at 32 ± 0.5°C. Delivery surface faces upwards towards the media. |
900 |
1, 3, 5, 7, 11, 16, 20 and 24 hours |
2011/06/30 |
| Testosterone |
Buccal Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Testosterone |
Pellet Implant |
|
|
Develop a dissolution method |
|
|
2008/11/25 |
| Testosterone Undecanoate |
Capsule |
II (Paddle) |
75 |
0.01 N HCl with 0.5% Triton X 100 |
900 |
5, 10, 15, 30, 45 and 60 |
2024/02/05 |
| Testosterone Undecanoate |
Capsule |
II (Paddle) |
75 |
Phosphate buffer pH 6.8 with 1.0% Triton X-100 |
900 |
10, 15, 20, 30 and 45 |
2021/08/19 |
| Tetrabenazine |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 30 and 45 |
2011/09/01 |
| Tetracycline HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Tetracycline HCl |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Thalidomide |
Capsule |
II (Paddle) |
100 |
1.5% (w/v) SLS (pH 3.0, adj w/ HCl) |
900 |
10, 20, 30, 60 and 90 |
2006/03/04 |
| Theophylline |
Capsule (Extended Release) |
|
|
Refer to USP |
900 |
|
2008/10/06 |
| Theophylline (100 mg and 200 mg) |
Tablet (Extended Release) |
II (Paddle) |
50 |
SGF without Enzyme, pH 1.2 during 1st hour. Phosphate Buffer at pH 7.5 from end of hour 1 through the duration of testing |
900 |
1, 4, 8, 12 hours |
2008/10/06 |
| Theophylline (300 mg and 450 mg) |
Tablet (Extended Release) |
II (Paddle) |
50 |
SGF without Enzyme, pH 1.2 during 1st hour. Phosphate Buffer at pH 7.5 from end of hour 1 through the duration of testing |
900 |
1, 4, 8, 12 hours |
2008/10/06 |
| Theophylline (600 mg and 400 mg) |
Tablet (Extended Release) |
I (Basket) |
100 |
SGF without enzyme, pH 1.2 during 1st hour. SIF without enzyme from end of hour 1 through the duration of the testing |
900 |
1, 2, 4, 8, 12 and 24 hours |
2008/10/06 |
| Thioguanine |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Tiagabine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Ticagrelor |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Ticlopidine HCl |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Timolol Maleate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Tinidazole |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Tiopronin |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Tiopronin |
Tablet (Delayed Release) |
I (Basket) |
100 |
Acid Stage: 0.1 N HCl; Buffer Stage: 50 mM Potassium phosphate, pH 6.8 |
Acid Stage: 900; Buffer Stage: 900 |
Acid Stage:120; Buffer Stage:10, 20, 30, 45 and 60 |
2022/07/07 |
| Tipiracil HCl/Trifluridine |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20 and 30 |
2017/11/02 |
| Tipranavir |
Capsule |
II (Paddle) |
50 |
0.05 M phosphate buffer pH 6.8 |
900 |
15, 30, 45 and 60 |
2007/12/03 |
| Tivozanib HCl |
Capsule |
II (Paddle with sinker) |
50 |
Tier I: 0.1 mM HCI with 0.5% (w/v) sodium dodecyl sulfate (SDS) (900 mL); Tier II: 0.1 mM HCI with pepsin (as per USP) (750 mL) for the first 10 minutes, followed by addition of 0.1 mM HCI with SDS (3% w/v) (150 mL) for the remainder of the dissolution |
900 |
5, 10, 15, 20 and 30 |
2023/02/09 |
| Tizanidine HCl |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Tizanidine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Tofacitinib Citrate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Tofacitinib Citrate |
Tablet (Extended Release) |
II (Paddle) with option to use a sinker |
50 |
Phosphate Buffer, pH 6.8 |
900 |
1, 1.5, 2, 2.5, 3, 4, 6 and 8 hours |
2016/07/28 |
| Tolcapone |
Tablet |
|
|
Refer to USP |
|
|
2013/05/09 |
| Tolterodine Tartrate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Tolterodine Tartrate |
Capsule (Extended Release) |
I (Basket) |
100 |
Phosphate buffer (pH 6.8) |
900 |
1, 3, 7 hours |
2007/06/18 |
| Tolvaptan |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Topiramate |
Capsule (Sprinkle) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Topiramate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Topiramate [25, 50, 100, 150 mg and 200 mg] |
Capsule (Extended Release) |
I (Basket) |
100 |
50 mM Tris buffer, pH 7.2 |
900 |
0.5, 1, 2, 4, 6 and 8 hours |
2015/06/25 |
| Topiramate [25, 50, 100 and 200 mg] |
Capsule (Extended Release) |
II (Paddle) |
50 |
0.05 M Phosphate Buffer, pH 7.5 |
750 |
1, 2, 3, 4, 6 and 8 hours |
2014/08/14 |
| Topotecan HCl |
Capsule |
II (Paddle) |
50 |
Acetate Buffer with 0.15% SDS, pH 4.5 |
500 |
5, 10, 20, 30 and 45 |
2009/04/27 |
| Toremifene Citrate |
Tablet |
II (Paddle) |
50 |
0.02 N HCl |
1000 |
10, 20, 30 and 45 |
2004/02/20 |
| Torsemide |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15 and 30 |
2004/02/20 |
| Torsemide [20, 40 and 60 mg] |
Tablet |
II (Paddle) |
75 |
0.1 N HCl |
900 |
1, 2, 3, 4, 6, 8 and 10 hours |
2022/07/07 |
| Tramadol |
Capsule (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Tramadol HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Tramadol HCl |
Tablet (Extended Release) |
I (Basket) |
75 |
0.1 N HCl |
900 |
2, 4, 8, 10 and 16 hours |
2007/01/03 |
| Trametinib Dimethyl Sulfoxide |
Tablet |
II (Paddle) |
60 |
pH 4.5, 50 mM Sodium Acetate with 0.75% Sodium Lauryl Sulfate [SLS] |
500 |
5, 10, 15, 20 and 30 |
2015/12/24 |
| Trandolapril |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Trandolapril/Verapamil HCl |
Tablet (Extended Release) |
II (Paddle) |
50 |
Trandolapril: Develop a dissolution method; Verapamil: 0-1 hour Gastric Fluid w/o Pepsin pH=1.2, 1-8 hour Intestinal Fluid w/o Pancreatin |
Verapamil: 900 |
Verapamil: 1, 2, 3.5, 5 and 8 hours |
2023/09/15 |
| Tranexamic Acid |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Tranylcypromine Sulfate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Trazodone HCl |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Trazodone HCl |
Tablet |
|
|
Refer to USP |
|
|
2023/05/18 |
| Treprostinil Diolamine |
Tablet (Extended Release) |
I (Basket) |
100 |
0.05 M Phosphate Buffer, pH 6.8 (deaerated) |
500 |
1, 2, 4, 6, 8, 12, 16, 20 and 24 hours |
2016/06/02 |
| Tretinoin |
Capsule |
I (Basket) |
100 |
0.5% solid Lauryldimethylamine-oxide (LDAO) in 0.05M Phosphate Buffer, pH 7.8 |
900 |
10, 15, 20, 30 and 45 |
2010/08/05 |
| Triamcinolone Acetonide |
Intra-Articular, For Suspension (Extended Release) |
II (Paddle) |
75 |
0.3% SDS in 10 mM phosphate buffer, pH 7.2 + 0.02% sodium azide @35°C |
1000 |
1, 2, 4, 8, 12, 16, 24, 36, 48, 72, 96 and 120 hours |
2018/02/08 |
| Triamcinolone Acetonide |
Injectable Suspension |
|
|
Develop a dissolution method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency |
|
|
2010/01/15 |
| Triclabendazole |
Tablet |
II (Paddle) |
75 |
0.1N HCl with 1% Tween 20 |
1000 |
5, 10, 15, 20 and 30 |
2020/08/27 |
| Trientine HCl |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Trimethoprim |
Tablet |
|
|
Refer to USP |
|
|
2010/01/29 |
| Trimipramine Maleate |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Triptorelin Pamoate |
For Intramuscular Suspension (Extended Release) |
II (Paddle) |
75 |
50 mL of methanol to 950 mL of water |
950 |
1, 8, 24, 96, and 168 hours |
2017/11/16 |
| Triptorelin Pamoate |
Injectable Suspension |
II (Paddle) |
200 |
Water-Methanol (95:5); Reconstitute vial in 2 mL Water for Injection, add to 500 mL medium at 37°C |
500 |
1, 6, 12, 24, 48 and 72 hours |
2008/07/14 |
| Trospium Chloride |
Capsule (Extended Release) |
II (Paddle) with sinker |
50 |
0.1 N HCl, pH 1.1 for 2 hrs and then add 200 mL of 0.1 N NaOH in 200 mM Phosphate Buffer. Adjust pH to 7.5 using 2 N HCl and/or 2N NaOH |
0-2 hrs: 750 ml, After 2 hrs: 950 ml. |
2, 3, 4, 6, 8, 12 and 16 hours |
2010/07/15 |
| Trospium Chloride |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Tucatinib |
Tablet |
II (Paddle) |
75 |
0.1 M Citrate Buffer, pH 3.4, containing 0.05% Brij 35 (polyoxyethylene lauryl ether) |
900 |
10, 15, 20, 30 and 45 |
2022/05/12 |
| Ulipristal Acetate |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20 and 30 |
2013/01/31 |
| Upadacitinib |
Tablet (Extended Release) |
I (Basket) |
100 |
50 mM Phosphate buffer, pH 6.8 [for 15 mg and 30 mg strengths]; 25 mM Phosphate buffer with 2.75% NaCl, pH 6.8 for [45 mg strength] |
900 |
1, 2, 4, 6, 8, 12 and 16 hours |
2023/02/09 |
| Uridine Triacetate |
Granule |
II (Paddle) |
60 |
50 mM
Phosphate
Buffer, pH 6.8 |
900 |
10, 15, 20, 30, 45 and 60 |
2022/07/07 |
| Ursodiol |
Capsules |
|
|
Refer to USP |
|
|
2009/07/21 |
| Ursodiol |
Tablet |
|
|
Refer to USP |
|
|
2008/04/15 |
| Valacyclovir Hydrochloride |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Valbenazine |
Capsule |
II (Paddle) with sinker |
50 |
Tier 1: 0.1N HCl; Tier 2: 0.1N HCl containing pepsin (750,000 units per 1000 mL) |
900 |
5, 10, 15, 20 and 30 |
2017/11/02 |
| Valbenazine |
Capsule (Sprinkle) |
I (Basket) |
50 |
0.1 N HCl |
900 |
5, 15, 20, 30 and 45 |
2014/11/15 |
| Valganciclovir HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Valproic Acid |
Capsule |
|
|
Refer to USP |
|
|
2009/12/15 |
| Valsartan |
Tablet |
|
|
Refer to USP |
|
|
2016/07/28 |
| Valsartan |
Capsule |
II (Paddle) |
50 |
0.067 M Phosphate Buffer, pH 6.8 |
1000 |
10, 20, 30 and 45 |
2004/12/13 |
| Vancomycin hydrochloride |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Vandetanib |
Tablet |
II (Paddle) |
50 |
pH 1.2 Buffer [0.05 M KCl in water, adjust the pH with HCl or NaOH] |
1000 |
5, 10, 15, 20 and 30 |
2015/06/25 |
| Vardenafil HCl |
Tablet (Orally Disintegrating) |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15 and 30 |
2014/05/15 |
| Vardenafil HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Varenicline Tartrate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Vemurafenib |
Tablet |
II (Paddle) |
75 |
1% hexadecyltrimethylammonium bromide (HTAB) in 0.05 M Phosphate Buffer, pH 6.8 |
900 |
10, 15, 20, 30 and 45 |
2015/05/28 |
| Venetoclax |
Tablet |
III (Reciprocating Cylinder) [Bottom Screen: 200 mesh stainless steel] |
20 dpm |
Phosphate Buffer, pH 6.8 with 0.4% sodium dodecyl sulfate (SDS) [3 small drops of antifoaming agent may be used] |
250 |
0.25, 0.5, 0.75, 1, 1.5, 2, 3, 3.5 and 4 hours |
2016/07/28 |
| Venlafaxine Besylate |
Tablet (Extended Release) |
II (Paddle with sinker) |
50 |
0.1 M NaCl in water (Degassed) |
900 |
1, 2, 4, 6, 8, 12, 14 and 16 hours |
2023/02/09 |
| Venlafaxine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Venlafaxine HCl |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Venlafaxine HCl |
Capsule (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Verapamil HCl |
Tablet |
|
|
Refer to USP |
|
|
2008/11/04 |
| Verapamil HCl |
Capsule (Extended Release) |
|
|
Refer to USP |
|
|
2015/08/27 |
| Verapamil HCl |
Tablet (Extended Release) |
|
|
Refer to USP |
|
|
2010/06/24 |
| Vericiguat |
Tablet |
II (Paddle) |
75 |
0.01 N HCl, pH 2.0 |
900 |
5, 10, 15, 20 and 30 |
2022/07/07 |
| Verteporfin |
Injectable |
|
|
Develop a method to characterize in vitro release. |
|
|
2014/08/14 |
| Vibegron |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2023/02/09 |
| Vigabatrin |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Vilazodone HCl |
Tablet |
II (Paddle) |
60 |
0.1% v/v Glacial acetic acid solution (pH 3.1) |
1000 |
10, 15, 20, 30 and 45 |
2014/08/14 |
| Viloxazine HCl |
Capsule (Extended Release) |
II (Paddle) with sinker |
50 |
pH 6.8 Phosphate Buffer |
900 |
1, 2, 4, 6, 8, 10, 12 and 16 hours |
2022/07/07 |
| Vismodegib |
Capsule |
II (Paddle) |
75 |
0.01 N HCl with 1.0% sodium lauryl sulfate (SLS) |
900 |
10, 15, 20, 30 and 45 |
2015/05/28 |
| Voclosporin |
Capsule |
II (Paddle) |
75 |
0.75% of Polyoxyl 40 hydrogenated castor oil in sodium acetate buffer (22mM), pH 4.5 |
900 |
10, 20, 30, 45 and 60 |
2023/02/09 |
| Vorapaxar Sulfate |
Tablet |
II (Paddle) |
50 |
41 mM Na2HPO4, 1.5% Citric Acid, pH 3.0 ± 0.5 |
900 |
5, 10, 20, 30, 45 and 60 |
2015/12/24 |
| Voriconazole |
Suspension |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 20, 30 and 45 |
2007/01/03 |
| Voriconazole |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 20, 30 and 45 |
2008/11/25 |
| Vorinostat |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Vortioxetine HBr |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 15, 20, 30 and 45 |
2015/05/28 |
| Voxelotor |
Tablet |
II (Paddle) |
75 |
50 mM phosphate buffer (pH 6.8) with 2% sodium lauryl sulfate (SLS) |
900 |
5, 10, 20, 30 and 45 |
2022/07/28 |
| Voxelotor |
Tablet, for Suspension |
II (Paddle) |
75 |
50 mM phosphate buffer (pH 6.8) with 2% sodium lauryl sulfate (SLS) |
900 |
5, 10, 15, 20 and 30 |
2022/07/28 |
| Warfarin Sodium |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Zafirlukast |
Tablet |
II (Paddle) |
50 |
1% w/v Aqueous Sodium Dodecyl Sulfate |
1000 |
10. 30, 30 and 45 |
2007/10/09 |
| Zalcitabine |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Zaleplon |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Zidovudine |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Zileuton |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Zileuton |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Zinc Acetate |
Capsule |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 20, 30 and 45 |
2004/02/19 |
| Ziprasidone HCl |
Capsule |
II (Paddle) |
75 |
Tier I: 0.05 M Na phosphate buffer, pH 7.5 + 2% SDS (w/w)
Tier II: 0.05 M Na phosphate buffer, pH 7.5 (700ml) + 1% pancreatin. After 15 min. incubation, add 200 mL of phosphate buffer containg 9% SDS |
900 |
10, 20, 30, 45 and 60 |
2006/03/04 |
| Zolmitriptan |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Zolmitriptan |
Tablet (Orally Disintegrating) |
II (Paddle) |
50 |
0.1 N HCl |
500 |
5, 10, 15, 20 and 30 |
2007/06/18 |
| Zolpidem Tartrate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Zolpidem Tartrate |
Tablet (Extended Release) |
|
|
Refer to USP |
|
|
2012/01/05 |
| Zolpidem Tartrate (1.75 and 3.5 mg) |
Tablet (Sublingual) |
II (Paddle) |
50 |
Simulated intestinal fluid (without enzyme), pH 6.8, (deaerated) |
500 |
1, 3, 5, 7, 10 and 15 |
2014/08/14 |
| Zolpidem Tartrate (5 and 10 mg) |
Tablet (Sublingual) |
II (Paddle) |
75 |
Phosphate Buffer, pH 6.8 |
900 |
1, 3, 5, 7, 10 and 15 |
2014/08/14 |
| Zonisamide |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
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