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
Ranitidine HCl Capsule Develop a dissolution method 2023/09/15
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
Ranolazine Tablet (Extended Release) Develop a dissolution method 2019/02/07
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
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
Ribavirin Tablet Develop a dissolution method 2023/09/15
Ribavirin Capsule Develop a dissolution method 2023/09/15
Ribociclib Tablet II (Paddle) 50 0.01N HCl (degassed) 900 10, 20, 30, 45 and 60 2022/05/12
Rifabutin Capsule Refer to USP 2009/12/15
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 Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30, 45 and 60 2004/02/18

数据库说明:

当前数据更新日期:2025年12月14日。
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