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
Aspirin/Dipyridamole Capsule I (Basket) 100 0.01 N HCl for first hour, 0.1 M Phosphate Buffer, pH 5.5, thereafter 0-1 hrs: 900 mL. 900 mL thereafter Acid: 10, 20, 30, 45 and 60 min; Buffer:1, 2, 5, and 7 hours 2007/10/09
Aspirin/Hydrocodone Bitartrate Tablet II (Paddle) 75 Acetate Buffer, pH 4.5 900 10, 20, 30, 45, 60 and 90 2004/01/15
Aspirin/Meprobamate Tablet Develop a dissolution method 2023/09/15
Aspirin/Methocarbamol Tablet Develop a dissolution method 2023/09/15
Aspirin/Oxycodone HCl Tablet Refer to USP 2010/01/15
Atazanavir Sulfate Capsule II (Paddle) 50 0.025 N HCl 1000 10, 20, 30 and 45 2006/01/20
Atazanavir Sulfate/ Cobicistat Tablet II (Paddle) 75 0.05 M Citrate Buffer (pH 2.8) 1000 Atazanavir: 10, 15, 20, 30 and 45; Cobicistat: 5, 10, 15, 20 and 30 2015/12/24
Atenolol Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Atenolol/Chlorthalidone Tablet Refer to USP 2014/02/14
Atogepant Tablet Refer to FDA's Dissolution Guidance, 2018 2023/05/18
Atomoxetine HCl Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Atorvastatin Calcium Tablet II (Paddle) 75 0.05 M Phosphate buffer, pH 6.8 900 5, 10, 15 and 30 2004/01/15
Atorvastatin Calcium Suspension II (Paddle) 75 0.05 M Phosphate Buffer, pH 6.8 900 5, 10, 15 and 30 2024/05/31
Atorvastatin Calcium/Ezetimibe Tablet II (Paddle), with option to use a sinker for 20/10 mg strength 75 Phosphate buffer, pH 6.8 with 0.2% w/v Tween 80 900 5, 10, 15, 20, 30 and 45 2014/05/15
Atovaquone Tablet II (Paddle) 50 40% isopropanol buffered to pH 8.0 with potassium dihydrogen phosphate 900 10, 20, 30, 45, 60 and 90 2007/06/18
Atovaquone Oral Suspension Develop a dissolution method 2009/07/21
Atovaquone/Proguanil HCl Tablet II (Paddle) with PEAK vessels 50 40% isopropranol buffered to pH 8.0 with potassium dihydrogen phosphate 900 15, 30, 45 and 60 2006/08/17
Atropine Sulfate/ Diphenoxylate HCl Tablet Develop dissolution method(s) to characterize the dissolution of both components 2016/12/22
Auranofin Capsule Develop a dissolution method 2023/09/15
Avacopan Capsule II (Paddle) with sinker 50 0.1N HCl 900 10, 20, 30, 45 and 60 2023/10/06

数据库说明:

当前数据更新日期:2025年12月07日。
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