FDA药品溶出方法数据库
(FDA-Recommended Dissolution Methods Database)
药品通用名称 剂型 USP溶出装置 速度 溶出介质 介质体积 建议取样时间(分钟) 更新日期
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 Suspension Develop a dissolution method 2023/09/15
Amoxicillin/Clavulanate Potassium Tablet (Chewable) 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

数据库说明:

当前数据更新日期:2024年09月01日。
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