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
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

数据库说明:

当前数据更新日期:2026年02月09日。
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