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
Rivastigmine Film, Transdermal Modified USP Type VI (cylinder) 50 0. 9 % NaCl at 32º C 500 1, 2, 4, 7, 9 and 12 hours 2009/06/10
Rivastigmine Tartrate Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Rizatriptan Benzoate Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Rizatriptan Benzoate Tablet, (Orally Disintegrating (ODT)) Develop a dissolution method 2024/01/03
Roflumilast Tablet II (Paddle) 50 1.0% SDS (sodium dodecyl sulfate) in Phosphate Buffer, pH 6.8 1000 5, 10, 15, 20, 30 and 45 2013/08/15
Rolapitant HCl Tablet II (Paddle) 50 0.05 M Sodium Acetate buffer, pH 4.0 900 10, 15, 20, 30 and 45 2016/10/20
Ropinirole HCl Tablet Refer to USP 2014/05/15
Ropinirole HCl Tablet (Extended Release) II (Paddle) 100 pH 4.0 Citrate-THAM Buffer 500 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours 2009/08/27
Rosuvastatin Calcium Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Rotigotine Transdermal 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
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

数据库说明:

当前数据更新日期:2025年12月14日。
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