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
Baricitinib Tablet II (Paddle) 75 Acetate buffer pH 4.5 900 5, 15, 30, 45 2023/03/30
Bedaquiline Fumarate Tablet I (Basket) 150 0.01 N HCl 900 10, 15, 20, 30 and 45 2013/06/06
Belzutifan Tablet II (Paddle) 50 50 mM potassium phosphate buffer at pH 6.5 with 68 mM potassium chloride (@37°C) 900 10, 15, 20, 30, 45 and 60 2023/07/07
Bempedoic Acid Tablet II (Paddle) 50 0.05 M Phosphate buffer, pH 6.6 900 5, 10, 15, 20 and 30 2021/08/19
Bempedoic Acid/Ezetimibe Tablet II (Paddle) 50 Bempedoic Acid: 0.05 M Phosphate buffer, pH 6.6; Ezetimibe: 0.05M Sodium Acetate Buffer pH 4.5 with 0.45% SLS 900 5, 10, 15, 20, 30, and 45 2021/08/19
Benazepril HCl Tablet Develop a dissolution method 2023/09/15
Benazepril HCl/Hydrochlorothiazide Tablet I (Basket) 100 0.1 N HCl 500 10, 20, 30 and 45 2004/01/16
Bendroflumethiazide/Nadolol Tablet Refer to USP 2007/07/25
Benzgalantamine Gluconate Tablet, Delayed Release I (Basket) 50 Acid Stage: 0.1N HCl; Buffer Stage: 0.05M Sodium Phosphate buffer pH 6.8 with 0.5% SDS 1000 Acid stage: 120; Buffer stage: 15, 20, 30, 45, 60 and 75 2025/06/23
Benzonatate Capsule Develop a dissolution method 2024/01/03
Benzoyl Peroxide; Clindamycin Phosphate Gel Develop a method to characterize in vitro release 2023/05/18
Benzphetamine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Bepridil HCl Tablet I (Basket) 100 0.1 N HCl 900 10, 20, 30, 45 and 60 2004/01/16
Berotralstat HCl Capsule Refer to FDA's Dissolution Guidance, 2018 2023/02/09
Betamethasone Acetate/Betamethasone Sodium Phosphate Injectable Suspension IV (Flow through cell) Flow @ 8 mL/min 0.05% SLS, pH 3.0 or Develop an in vitro release method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, and 360 2010/04/08
Bethanechol Chloride Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Bethanechol Chloride Tablet Refer to USP 2008/10/06
Betrixaban Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Bexagliflozin Tablet I (Basket) 50 0.1 N HCl 900 1, 3, 5, 8 and 10 hours 2024/05/31
Bexarotene Capsule II (Paddle) 50 Tier 1 Medium: 0.5% HDTMA in 0.05 M phosphate buffer, pH 7.5 Tier 2 Medium: 0.5% HDTMA in 0.05 M phosphate buffer, pH 7.5 with 0.05 g/L pancreatin enzyme 900 15, 30, 45 and 60 2006/08/17

数据库说明:

当前数据更新日期:2025年12月07日。
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