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
Ezetimibe Tablet II (Paddle) 50 0.45% SLS in 0.05 M Acetate Buffer, pH 4.5 500 10, 20, 30 and 45 2008/01/14
Ezetimibe/Simvastatin Tablet II (Paddle) 50 0.01 M Sodium Phosphate, pH 7.0/0.5% SDS 900 5, 10, 20 and 30 2007/01/03
Ezogabine Tablet II (Paddle) 75 0.01 N HCl 1000 5, 10, 15, 20 and 30 2013/08/15
Famciclovir Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Famotidine Tablet Refer to USP 2023/02/09
Famotidine Tablet (Orally Disintegrating) II (Paddle) 50 0.1 M Phosphate Buffer, pH 4.5 900 2, 5, 10, 15 and 20 2008/10/06
Famotidine Tablet (Chewable) II (Paddle) 50 0.1 M Phosphate Buffer, pH 4.5 900 10, 20, 30, 45 and 60 2004/01/29
Famotidine Suspension II (Paddle) 25 and 50 0.1 M Phosphate buffer, pH 4.5 900 10, 15, 30 and 45 2008/11/25
Famotidine/Calcium Carbonate/Magnesium Hydroxide Tablet (Chewable) Develop a dissolution method 2009/12/15
Famotidine/Ibuprofen Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 7.2 900 5, 10, 15, 20, 30 and 45 2013/08/15
Febuxostat Tablet II (Paddle) 75 0.05 M Phosphate Buffer, pH 6.0 900 5, 10, 15, 20 and 30 2013/08/15
Fedratinib HCl Capsule I (Basket) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 2021/08/19
Felbamate Tablet Develop a dissolution method 2024/01/03
Felbamate Suspension Develop a dissolution method 2023/09/15
Felodipine Tablet (Extended Release) Develop a dissolution method 2024/01/03
Fenofibrate Capsule II (Paddle) 75 Phosphate Buffer w/ 2% Tween 80 and 0.1% pancreatin, pH 6.8 900 15, 30, 45, 60, 90 and 120 2008/02/19
Fenofibrate Capsule (Micronized) Develop a dissolution method 2023/09/15
Fenofibrate (40 mg and 120 mg) Tablet Develop a dissolution method 2023/09/15
Fenofibrate (48 mg and 145 mg) Tablet Develop a dissolution method 2023/09/15
Fenofibrate (54 mg and 160 mg) Tablet Develop a dissolution method 2023/09/15

数据库说明:

当前数据更新日期:2026年04月23日。
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