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
Rabeprazole Sodium Tablet (Delayed Release) II (Paddle) 100 700 mL 0.1 N HCl (Acid stage), after two hours add 300 mL of 0.6 M Tris buffer; adjust to pH 8.0 (Buffer stage) with 2 N HCl or 2 N NaOH . Stabilize the samples with the addition of 0.5 N NaOH Acid stage: 700; Buffer stage: 1000 Acid stage: 120; Buffer stage: 10, 20, 30, and 45 2011/09/22
Raloxifene HCl Tablet Develop a dissolution method 2023/09/15
Raltegravir Potassium Tablet (Chewable) Develop a dissolution method 2023/09/15
Raltegravir Potassium Tablet Develop a dissolution method 2023/09/15
Ramelteon Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Ramipril Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Ramipril Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Ranitidine HCl Tablet Develop a dissolution method 2024/01/03
Ranitidine HCl Capsule Develop a dissolution method 2023/09/15
Ranitidine HCl Tablet (Effervescent) Develop a dissolution method 2010/04/08
Ranolazine Tablet (Extended Release) Develop a dissolution method 2019/02/07
Ranolazine Granules (Extended Release) II (Paddle) 50 0.1 N HCl 900 0.5, 1, 2, 3, 4, 6 and 8 hours 2022/07/07
Rasagiline Mesylate Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Regorafenib Tablet II (Paddle) 75 Acetate Buffer pH 4.5 with 0.1% Sodium Dodecyl Sulfate (SDS) 900 10, 15, 20, 30 and 45 2015/06/25
Relacorilant Capsule II (Paddle) 100 Tier I: 25 mg: 0.1 N HCl with 0.15% (w/v) Tween 80; 100 mg: 0.1 N HCl with 0.5% (w/v) Tween 80; Tier II: same as Tier I with the addition of NMT 750,000 unitl/L Pepsin 900 5, 10, 15, 20, 30, 45 and 60 2026/05/22
Relugolix Tablet II (Paddle) 50 50 mM Citrate Buffer, pH 5.5 900 5, 10, 15, 20 and 30 2022/07/07
Repaglinide Tablet Refer to USP 2007/07/25
Repotrectinib Capsule II (Paddle) with sinker 75 50 mM Sodium Phosphate Buffer, pH 6.8, w/ 0.075% SLS 900 5, 10, 15, 30, 45, 60 and 75 2025/06/23
Resmetirom Tablet Develop a dissolution method 2024/09/03
Revumenib Citrate Tablet Refer to FDA's Dissolution Guidance, 2018 2026/01/28

数据库说明:

当前数据更新日期:2026年06月12日。
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