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
Tacrolimus For Suspension II (Paddle) 50 Hydroxypropyl Cellulose Solution (1 in 20,000). Adjust to pH 4.5 by Phosphoric Acid 15, 30, 45, 60, 90 and 120 2023/02/09
Tadalafil Tablet II (Paddle) 50 0.5% Sodium Lauryl Sulfate 1000 10, 20, 30 and 45 2006/01/26
Tafamidis Capsule II (Paddle) with sinker 75 Tier 1 Medium: 0.05M Sodium Phosphate Buffer, pH 6.8 with 1.0% Tween 80; Tier II Medium: 0.05M Sodium Phosphate Buffer, pH 6.8 with 1.0% Tween 80 and enzyme with protease activity as per USP 900 5, 10, 15, 20, 30 and 45 2021/04/22
Tafamidis Meglumine Capsule II (Paddle) with sinker 75 Tier 1 Medium: 0.05M Sodium Phosphate Buffer, pH 6.8. Tier 2 Medium: 0.05M Sodium Phosphate Buffer, pH 6.8, and pancreatin with protease activity as per USP 900 5, 10, 15, 20, 30 and 45 2021/04/22
Tafenoquine Succinate Tablet II (Paddle) 75 0.01M Sodium phosphate buffer, pH 6.8, with 0.20% w/v of Polysorbate 20 900 5, 10, 20, 30, 45 and 60 2020/08/27
Talazoparib Tosylate Capsule II (Paddle) with sinker 75 0.01 N HCl with 0.2% sodium dodecyl sulfate (SDS), 500 10, 15, 20, 30 and 45 2020/08/27
Tamoxifen Citrate Tablet Refer to USP 2009/04/02
Tamsulosin HCl Capsule II (Paddle) 100 0-2 hours: 0.003% polysorbate 80, pH 1.2 2-8 hours: phosphate buffer, pH 7.2 500 1, 2, 3, 6, 8, and 10 hours 2007/03/26
Tapentadol HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Tapentadol HCl Tablet (Extended Release) II (Paddle) with sinker 100 0.05 M Phosphate Buffer of pH 6.8, Simulated intestinal fluid (without enzyme) 900 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours 2013/10/31
Tasimelteon Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Tasimelteon Suspension Refer to FDA's Dissolution Guidance, 2018 2024/05/31
Tazemetostat Hydrobromide Tablet II (Paddle) 50 0.01 N HCl 900 5, 10, 15, 20, 30 and 45 2022/05/12
Tedizolid Phosphate Tablet II (Paddle) 60 0.05 M phosphate buffer pH 6.8 900 5, 10, 15, 20 and 30 2016/06/02
Tegaserod Maleate Tablet Develop a dissolution method 2023/09/15
Telaprevir Tablet Develop a dissolution method 2023/09/15
Telbivudine Tablet II (Paddle) 50 0.1 N HCl 900 15, 30 and 45 2009/04/02
Telithromycin Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 2007/01/03
Telmisartan Tablet Refer to USP 2012/01/05
Temazepam Capsule Refer to USP 2008/01/14

数据库说明:

当前数据更新日期:2025年03月07日。
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