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
Topiramate [25, 50, 100, 150 mg and 200 mg] Capsule (Extended Release) I (Basket) 100 50 mM Tris buffer, pH 7.2 900 0.5, 1, 2, 4, 6 and 8 hours 2015/06/25
Topiramate [25, 50, 100 and 200 mg] Capsule (Extended Release) II (Paddle) 50 0.05 M Phosphate Buffer, pH 7.5 750 1, 2, 3, 4, 6 and 8 hours 2014/08/14
Topotecan HCl Capsule II (Paddle) 50 Acetate Buffer with 0.15% SDS, pH 4.5 500 5, 10, 20, 30 and 45 2009/04/27
Toremifene Citrate Tablet II (Paddle) 50 0.02 N HCl 1000 10, 20, 30 and 45 2004/02/20
Torsemide Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15 and 30 2004/02/20
Torsemide [20, 40 and 60 mg] Tablet II (Paddle) 75 0.1 N HCl 900 1, 2, 3, 4, 6, 8 and 10 hours 2022/07/07
Tramadol Capsule (Extended Release) Develop a dissolution method 2023/09/15
Tramadol HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Tramadol HCl Tablet (Extended Release) I (Basket) 75 0.1 N HCl 900 2, 4, 8, 10 and 16 hours 2007/01/03
Trametinib Dimethyl Sulfoxide Tablet II (Paddle) 60 pH 4.5, 50 mM Sodium Acetate with 0.75% Sodium Lauryl Sulfate [SLS] 500 5, 10, 15, 20 and 30 2015/12/24
Trandolapril Tablet Develop a dissolution method 2023/09/15
Trandolapril/Verapamil HCl Tablet (Extended Release) II (Paddle) 50 Trandolapril: Develop a dissolution method; Verapamil: 0-1 hour Gastric Fluid w/o Pepsin pH=1.2, 1-8 hour Intestinal Fluid w/o Pancreatin Verapamil: 900 Verapamil: 1, 2, 3.5, 5 and 8 hours 2023/09/15
Tranexamic Acid Tablet Develop a dissolution method 2023/09/15
Tranylcypromine Sulfate Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Trazodone HCl Tablet (Extended Release) Develop a dissolution method 2023/09/15
Trazodone HCl Tablet Refer to USP 2023/05/18
Treprostinil Diolamine Tablet (Extended Release) I (Basket) 100 0.05 M Phosphate Buffer, pH 6.8 (deaerated) 500 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours 2016/06/02
Tretinoin Capsule I (Basket) 100 0.5% solid Lauryldimethylamine-oxide (LDAO) in 0.05M Phosphate Buffer, pH 7.8 900 10, 15, 20, 30 and 45 2010/08/05
Triamcinolone Acetonide Injectable Suspension Develop a dissolution method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency 2010/01/15
Triamcinolone Acetonide Intra-Articular, For Suspension (Extended Release) II (Paddle) 75 0.3% SDS in 10 mM phosphate buffer, pH 7.2 + 0.02% sodium azide @35°C 1000 1, 2, 4, 8, 12, 16, 24, 36, 48, 72, 96 and 120 hours 2018/02/08

数据库说明:

当前数据更新日期:2025年01月10日。
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