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
Pyrazinamide Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Pyridostigmine Bromide Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Pyridostigmine Bromide Tablet (Extended Release) Develop a dissolution method 2023/09/15
Pyrimethamine Tablet Refer to USP 2015/06/25
Quetiapine Fumarate Tablet (Extended Release) I (Basket, with 20 mesh) 200 0.05M citric acid and 0.09 N NaOH (pH 4.8) [solution A]. At 5 hrs, pH adjusted to 6.6 by addition of 100 mL of 0.05M dibasic sodium phosphate and 0.46N NaOH [solution B] 900 [solution A]. 1000 [final] 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 hours 2013/01/31
Quetiapine Fumarate Tablet Develop a dissolution method 2023/09/15
Quinapril HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Quinidine Gluconate Tablet (Extended Release) Refer to USP 2021/04/22
Quinine Sulfate Capsule Refer to USP 2008/01/14
Quizartinib Dihydrochloride Tablet II (Paddle) 50 0.1 N HCl 900 15, 20, 30, 45, and 60 2024/11/01
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
Rabeprazole Sodium Capsule (Delayed Release) II (Paddle) Acid Stage: 75 rpm; Buffer Stage: 60 rpm Acid Stage:0.1 N HCl; Buffer Stage: 0.05 M Phosphate Buffer, pH 6.8 (After Acid Stage, add 250 mL of 0.2 mol/L trisodium phosphate solution). Acid Stage: 750; Buffer Stage:1000 Acid Stage: 120; Buffer Stage: 10, 15, 20, 25, 30 and 45 2014/05/15
Raloxifene HCl Tablet Develop a dissolution method 2023/09/15
Raltegravir Potassium Tablet Develop a dissolution method 2023/09/15
Raltegravir Potassium Tablet (Chewable) 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 (Effervescent) Develop a dissolution method 2010/04/08
Ranitidine HCl Tablet Develop a dissolution method 2024/01/03

数据库说明:

当前数据更新日期:2025年12月15日。
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