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
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 Refer to USP 2023/05/18
Trazodone HCl Tablet (Extended Release) Develop a dissolution method 2023/09/15
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 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
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
Triclabendazole Tablet II (Paddle) 75 0.1N HCl with 1% Tween 20 1000 5, 10, 15, 20 and 30 2020/08/27
Trientine HCl Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Trimethoprim Tablet Refer to USP 2010/01/29
Trimipramine Maleate Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Triptorelin Pamoate For Intramuscular Suspension (Extended Release) II (Paddle) 75 50 mL of methanol to 950 mL of water 950 1, 8, 24, 96, and 168 hours 2017/11/16
Triptorelin Pamoate Injectable Suspension II (Paddle) 200 Water-Methanol (95:5); Reconstitute vial in 2 mL Water for Injection, add to 500 mL medium at 37°C 500 1, 6, 12, 24, 48 and 72 hours 2008/07/14
Trospium Chloride Capsule (Extended Release) II (Paddle) with sinker 50 0.1 N HCl, pH 1.1 for 2 hrs and then add 200 mL of 0.1 N NaOH in 200 mM Phosphate Buffer. Adjust pH to 7.5 using 2 N HCl and/or 2N NaOH 0-2 hrs: 750 ml, After 2 hrs: 950 ml. 2, 3, 4, 6, 8, 12 and 16 hours 2010/07/15
Trospium Chloride Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Tucatinib Tablet II (Paddle) 75 0.1 M Citrate Buffer, pH 3.4, containing 0.05% Brij 35 (polyoxyethylene lauryl ether) 900 10, 15, 20, 30 and 45 2022/05/12
Ulipristal Acetate Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 2013/01/31
Upadacitinib Tablet (Extended Release) I (Basket) 100 50 mM Phosphate buffer, pH 6.8 [for 15 mg and 30 mg strengths]; 25 mM Phosphate buffer with 2.75% NaCl, pH 6.8 for [45 mg strength] 900 1, 2, 4, 6, 8, 12 and 16 hours 2023/02/09
Uridine Triacetate Granule II (Paddle) 60 50 mM Phosphate Buffer, pH 6.8 900 10, 15, 20, 30, 45 and 60 2022/07/07

数据库说明:

当前数据更新日期:2024年10月06日。
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