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
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
Ursodiol Capsules Refer to USP 2009/07/21
Ursodiol Tablet Refer to USP 2008/04/15
Valacyclovir Hydrochloride Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Valbenazine Capsule II (Paddle) with sinker 50 Tier 1: 0.1N HCl; Tier 2: 0.1N HCl containing pepsin (750,000 units per 1000 mL) 900 5, 10, 15, 20 and 30 2017/11/02
Valbenazine Capsule (Sprinkle) I (Basket) 50 0.1 N HCl 900 5, 15, 20, 30 and 45 2024/11/15
Valganciclovir HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Valproic Acid Capsule Refer to USP 2009/12/15
Valsartan Tablet Refer to USP 2016/07/28

数据库说明:

当前数据更新日期:2025年01月10日。
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