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
Rifampin Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Rifamycin Sodium Tablet (Delayed Release) II (Paddle) 100 Acid stage: HCl 0.1 N with 0.5% w/v Macrogol Cetostearyl Ether; Buffer stage: pH 7.2 Sodium Phosphate buffer Acid Stage: 2 hours; Buffer Stage: 1, 2, 3 and 4 hours 2021/04/22
Rifapentine Tablet II (Paddle) 50 0.8% SLS in Phosphate Buffer, pH 7.0 900 10, 20, 30, 45, 60 and 90 2004/02/25
Rifaximin (200 mg) Tablet II (Paddle) 75 0.1M sodium phosphate buffer pH 7.4 containing 0.45% Sodium Lauryl Sulfate 1000 10, 20, 30, 45, 60, 90 and 120 2011/07/21
Rifaximin (550 mg) Tablet II (Paddle) 75 0.1M sodium phosphate buffer pH 7.4 containing 0.8% Sodium Lauryl Sulfate 1000 10, 20, 30, 45, 60, 90 and 120 2011/07/21
Rilpivirine HCl Tablet II (Paddle) 75 0.5% Polysorbate 20 in 0.01N HCl (pH=2.0) 900 10, 20, 30, 45 and 60 2013/08/15
Riluzole Suspension II (Paddle) 35 Phosphate Buffer pH 4.5 900 [890 mL of medium + 10 mL of suspension] 5, 10, 20, 30, 45 and 60 2022/05/12
Riluzole Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30, 45 and 60 2004/02/18
Rimantadine HCl Tablet Develop a dissolution method 2023/09/15
Rimegepant Sulfate Tablet, (Orally Disintegrating (ODT)) II (Paddle) 50 50 mM Sodium Acetate Buffer, pH 4.5 500 5, 10, 15, 20 and 30 2022/05/12
Rimexolone Ophthalmic Suspension Develop a method to characterize in vitro release 2016/06/30
Riociguat Tablet II (Paddle) 75 pH 6.8 Phosphate Buffer with 0.1% Sodium Lauryl Sulfate [SLS] 900 5, 10, 15, 20 and 30 2015/12/24
Ripretinib Tablet II (Paddle) 75 10 mM Sodium Acetate Buffer, pH 4.5, containing 0.25% (w/v) sodium dodecyl sulfate (SDS) 900 5, 10, 15, 20, 30 and 45 2022/05/12
Risedronate Sodium Tablet Develop a dissolution method 2024/01/03
Risedronate Sodium Tablet (Delayed Release) II (Paddle) 75 Acid stage: 0.1 N HCl; Buffer stage: Phosphate buffer, pH 6.8 Acid stage: 500; Buffer stage: 500 Acid stage: 120; Buffer Stage: 10, 15, 20, 30 and 45 2012/01/26
Risedronate Sodium/Calcium Carbonate Tablet (Copackaged) For Risedronate Tablets: Refer to USP; For Calcium Carbonate Tablets: Refer to USP. 2010/07/01
Risperidone Injectable Develop a dissolution method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency 2010/01/15
Risperidone Tablet II (Paddle) 50 0.1 N HCl 500 10, 20, 30, 45 and 60 2006/03/04
Risperidone Tablet (Orally Disintegrating) II (Paddle) 50 0.1 N HCl 500 5, 10, 15 2004/07/23
Risperidone For Suspension (Extended Release) IV (Flow thru cell-closed loop) 50 mM Potassium Phosphate Buffer, pH 7.4 1000 8, 24, 96, 120, 144, 168, 192, 216 and 264 hours 2025/06/23

数据库说明:

当前数据更新日期:2026年02月10日。
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