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
Acetaminophen/Hydrocodone Bitartrate Tablet Refer to USP (provide individual unit data). 2013/08/15
Acetaminophen/Ibuprofen Tablet II (Paddle) 50 50 mM Phosphate Buffer, pH 7.2 900 5, 10, 15, 20, and 30 2023/02/09
Acetaminophen/Oxycodone Tablet Refer to USP 2008/01/14
Acetaminophen/Oxycodone HCl Tablet (Extended Release) II (Paddle) with sinker 100 0.1 N HCl 900 0.25, 0.5, 1, 2, 4, 6 and 8 hours 2015/11/19
Acetaminophen/Pentazocine HCl Tablet Develop a dissolution method 2023/09/15
Acetaminophen/Tramadol HCl Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 2006/03/04
Acetaminophen; Butalbital Capsule Develop a dissolution method 2024/02/05
Acetazolamide Capsule (Extended Release) II (Paddle) 75 Acetate Buffer, pH 4.5 with 2.2% Tween 20 900 1, 2, 5, 7, 9, 12 and 14 hours 2010/01/15
Acetazolomide Tablet Develop a dissolution method 2024/01/03
Acetylcysteine Tablet (Effervescent) Develop a dissolution method 2016/07/28
Acitretin Capsule Refer to USP 2011/09/22
Acrivastine/Pseudoephedrine HCl Capsule II (Paddle) 50 0.01 N HCl 900 5, 10, 15 and 30 2004/01/12
Acyclovir Suspension II (Paddle) 50 0.1 N HCl 900 10, 20, 30, 45 and 60 2004/02/20
Acyclovir Tablet Refer to USP 2007/06/18
Acyclovir Capsule Refer to USP 2012/01/05
Acyclovir Tablet (Buccal) I (Basket) 60 Phosphate Buffer, pH 6.0 1000 1, 2, 3, 5, 7, 9 and 12 hours 2015/08/27
Adagrasib Tablet II (Paddle) 75 pH 6.8 phosphate buffer with 0.3% SLS 900 10, 15, 30, 45 and 60 2024/02/05
Adefovir Dipivoxil Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Afamelanotide Implant Develop a method to characterize in vitro release 2023/05/18
Afatinib Dimaleate Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02

数据库说明:

当前数据更新日期:2024年05月17日。
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