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
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 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
Selpercatinib Tablet II (Paddle) 75 0.1 N HCl 900 5, 10, 15, 20 and 30 2026/01/28
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

数据库说明:

当前数据更新日期:2026年02月09日。
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