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
Rotigotine Film, Extended Release 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
Sacubitril; Valsartan Capsule, Pellets I (Basket) 50 Phosphate Buffer, pH 6.8 900 5, 10, 15, 20, 30, 45 and 60 2026/01/28
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 System 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
Sebetralstat Tablet II (Paddle) 50 Acetate Buffer, pH 4.5 with 0.5% SLS 1000 5, 10, 15, 20, 30, 45 and 60 2026/03/25
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) Film, Extended Release 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) Film, Extended Release 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

数据库说明:

当前数据更新日期:2026年04月19日。
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