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
Thalidomide Capsule II (Paddle) 100 1.5% (w/v) SLS (pH 3.0, adj w/ HCl) 900 10, 20, 30, 60 and 90 2006/03/04
Theophylline Capsule (Extended Release) Refer to USP 900 2008/10/06
Theophylline (100 mg and 200 mg) Tablet (Extended Release) II (Paddle) 50 SGF without Enzyme, pH 1.2 during 1st hour. Phosphate Buffer at pH 7.5 from end of hour 1 through the duration of testing 900 1, 4, 8, 12 hours 2008/10/06
Theophylline (300 mg and 450 mg) Tablet (Extended Release) II (Paddle) 50 SGF without Enzyme, pH 1.2 during 1st hour. Phosphate Buffer at pH 7.5 from end of hour 1 through the duration of testing 900 1, 4, 8, 12 hours 2008/10/06
Theophylline (600 mg and 400 mg) Tablet (Extended Release) I (Basket) 100 SGF without enzyme, pH 1.2 during 1st hour. SIF without enzyme from end of hour 1 through the duration of the testing 900 1, 2, 4, 8, 12 and 24 hours 2008/10/06
Thioguanine Tablet Develop a dissolution method 2024/01/03
Tiagabine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Ticagrelor Tablet Develop a dissolution method 2023/09/15
Ticlopidine HCl Tablet Develop a dissolution method 2023/09/15
Timolol Maleate Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Tinidazole Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Tiopronin Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Tiopronin Tablet (Delayed Release) I (Basket) 100 Acid Stage: 0.1 N HCl; Buffer Stage: 50 mM Potassium phosphate, pH 6.8 Acid Stage: 900; Buffer Stage: 900 Acid Stage:120; Buffer Stage:10, 20, 30, 45 and 60 2022/07/07
Tipiracil HCl/Trifluridine Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 2017/11/02
Tipranavir Capsule II (Paddle) 50 0.05 M phosphate buffer pH 6.8 900 15, 30, 45 and 60 2007/12/03
Tivozanib HCl Capsule II (Paddle with sinker) 50 Tier I: 0.1 mM HCI with 0.5% (w/v) sodium dodecyl sulfate (SDS) (900 mL); Tier II: 0.1 mM HCI with pepsin (as per USP) (750 mL) for the first 10 minutes, followed by addition of 0.1 mM HCI with SDS (3% w/v) (150 mL) for the remainder of the dissolution 900 5, 10, 15, 20 and 30 2023/02/09
Tizanidine HCl Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Tizanidine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Tofacitinib Citrate Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Tofacitinib Citrate Tablet (Extended Release) II (Paddle) with option to use a sinker 50 Phosphate Buffer, pH 6.8 900 1, 1.5, 2, 2.5, 3, 4, 6 and 8 hours 2016/07/28

数据库说明:

当前数据更新日期:2025年04月08日。
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