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
Avanafil Tablet II (Paddle) 50 Simulated gastric fluid without pepsin. 900 5, 10, 15, 20 and 30 2015/04/02
Avapritinib Tablet II (Paddle) 75 0.05 M Sodium Acetate Buffer, pH 5.0 containing 0.5% w/v cetyl trimethylammonium bromide (CTAB) 900 5, 10, 15, 20, 30, 45, 60, 90 and 120 2022/05/12
Axitinib Tablet II (Paddle) 75 0.01 N HCl 900 5, 15, 30, 45 and 60 2014/08/14
Azacitidine Tablet II (Paddle) 75 50 mM phosphate buffer, pH 6.8 500 5, 10, 15, 20, 30 and 45 2023/11/30
Azacitidine Injectable Suspension Develop a dissolution method 2008/09/03
Azathioprine Tablet Develop a dissolution method 2024/01/03
Azilsartan Kamedoxomil Tablet II (Paddle) 50 Phosphate Buffer, pH 7.8 (deaerated) 900 5, 10, 15, 20, 30 and 45 2013/05/09
Azilsartan Kamedoxomil/Chlorthalidone Tablet II (Paddle) 50 Phosphate Buffer, pH 6.8 containing 1.0% Tween 80, 900 5, 10, 15, 20, 30 and 45 2013/05/09
Azithromycin Suspension (Extended Release) II (Paddle) 50 Phosphate Buffer, pH 6.0 900 15, 30, 45, 60, 120 and 180 2008/04/15
Azithromycin Oral Suspension II (Paddle) 50 Phosphate buffer, pH 6.0 900 10, 20, 30, and 45 2006/08/17
Azithromycin Tablet Refer to USP 2016/12/22
Azithromycin Capsule Refer to USP 2016/12/22
Baclofen Suspension II (Paddle) 25 0.01 N HCl 500 5, 10, 15, 30, 45 and 60 2024/05/31
Baclofen Granules II (Paddle) 50 0.01 N HCl 500 5, 10, 15 and 30 2024/02/05
Baclofen Tablet Refer to USP 2009/12/15
Baclofen Tablet (Orally Disintegrating) II (Paddle) 25 50 mM Acetate Buffer, pH 4.5 500 mL (10 mg) or 1000 mL (20mg) 5, 10, 15 and 30 2008/07/14
Baloxavir Marboxil Tablet II (paddle) 50 20 mg: Phosphate Buffer, pH 6.8 with 0.07% w/v (CTAB); 40 mg: Phosphate Buffer, pH 6.8 with 0.16% w/v CTAB; 80 mg: Phosphate Buffer, pH 6.8 with 0.40 w/v cetyltrimethylammonium bromide (CTAB) 900 5, 10, 15, 20, 30 and 45 2023/07/07
Baloxavir Marboxil For Suspension II (Paddle) 25 Phosphate Buffer, pH 6.8 containing 0.16% w/v cetyl trimethylammonium bromide (CTAB) 900 5, 10, 15, 20 and 30 2023/02/09
Balsalazide Disodium Capsule II (Paddle) with sinker 50 pH 6.8 buffer 900 10, 20, 30, and 45 2006/01/26
Balsalazide Disodium Tablet Develop a dissolution method 2023/09/15

数据库说明:

当前数据更新日期:2025年12月07日。
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