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
Colesevelam HCl Tablet Disintegration Testing as per USP <701> in various media such as simulated gastric fluid and simulated intestinal fluid. 2010/10/28
Crizotinib Capsule I (Basket) 100 0.1N HCl (degassed) 900 5, 10, 15, 30 and 45 2016/04/14
Crofelemer Tablet (Delayed Release) II (Paddle) 75 Acid stage: 0.1 N HCl; Buffer stage: Sodium phosphate buffer, pH 6.8 Acid stage: 750; Buffer stage: 1000 Acid stage: 2 hours; Buffer stage: : 5, 10, 20, 30 and 45 minutes 2016/06/02
Cyclobenzaprine Capsule (Extended Release) Refer to USP 2016/10/20
Cyclobenzaprine HCl Tablet Refer to USP 2007/07/25
Cyclophosphamide Tablet Develop a dissolution method 2023/09/15
Cycloserine Capsule Develop a dissolution method 2024/01/03
Cyclosporine (100 mg) (AB1) Capsule (Liquid filled) II (Paddle) 75 0.1 N HCl containing 4 mg of N,N-dimethydodecylamine-N-oxide per mL 1000 10, 20, 30, 45, 60 and 90 2008/01/14
Cyproheptadine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Cysteamine Bitartrate Granule (Delayed Release) I (Basket 75 rpm (for 75 mg strength); 150 rpm (for 300 mg strength) Acid Stage: 0.1 N HCl; Buffer Stage: 0.2M Sodium Phosphate buffer, pH 6.8 Acid Stage: 1000; Buffer Stage:1000 Acid Stage: 120; Buffer Stage: 5, 10, 15, 20 and 30 2020/08/27
Cysteamine Bitartrate Capsule (Delayed Release) I (Basket) 75 Acid stage: 0.1N HCl; Buffer stage: 0.05 M Sodium Phosphate buffer, pH 6.8 Acid stage: 1000; Buffer stage: 1000 Acid stage: 2 hours; Buffer stage: : 5, 10, 15, 20 and 30 minutes 2015/08/27
Cysteamine Bitartrate Capsule I (Basket) 75 0.1 N HCl 900 10, 20, 30 and 45 2004/01/24
Dabigatran Etexilate Mesylate Capsule I (Basket) for 75 strength: I (Basket with modified diameter of 24.5 mm) for 150 mg strength: 100 0.01 N HCl (pH 2.0) 900 10, 20, 30, and 45 2011/09/22
Dabrafenib Mesylate Capsule II (Paddle) 65 0.2% Cetyl trimethylammonium bromide (CTAB) in 0.1N HCl 900 10, 15, 20, 30 and 45 2015/05/28
Daclatasvir Dihydrochloride Tablet II (Paddle) 75 Phosphate Buffer, pH 6.8  with 0.75% Brij 35 1000 10, 15, 20, 30 and 45 2016/03/17
Dalfampridine Tablet (Extended Release) II (Paddle) 50 Phosphate Buffer, pH 6.8 900 0.5, 1, 2, 4, 6, 8, 10 and 12 hours 2012/06/07
Danazol Capsule Refer to USP 2007/06/18
Dantrolene Sodium For suspension (Intravenous ) II (Paddle) 50 0.5% Benzalkonium Chloride in water 900 0.5, 1, 2, 3, 5 and 10 2017/03/02
Dantrolene Sodium Capsule I (Basket) 100 0.5% Hyamine 10X in water, adjust to pH 6.8 with 0.1 N KOH or 0.1 N HCl 900 10, 20, 30, 40 and 60 2004/01/27
Dapagliflozin Propanediol Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02

数据库说明:

当前数据更新日期:2025年12月09日。
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