| 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 |