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
Tepotinib HCl Tablet II (Paddle) 50 Acetate buffer, pH 4.5 + 1 mM NaCl + 0.1% polysorbate 80 900 5, 15, 20 and 35 2023/03/30
Terazosin HCl Tablet Develop a dissolution method 2023/09/15
Terazosin HCl Capsule Develop a dissolution method 2023/09/15
Terbinafine HCl Tablet II (Paddle) 50 Citrate Buffer, pH 3.0 adjusted with HCl 500 10, 20, 30 and 45 2004/02/20
Terconazole Suppository (Vaginal) I (with Palmieri type basket) 100 0.12 N HCl with 1% SLS 900 15, 30, 45, 60, 90, 120 and 150 2009/10/08
Teriflunomide Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 6.8 1000 5, 10, 15, 20, 30 and 45 2014/05/15
Testosterone Film, Transdermal (Extended Release) V (Paddle over disk). Paddle 25 mm above the film on the disk. 50 0.1 M sodium chloride containing 2.5% (v/v) of Tween 40 at 32 ± 0.5°C. Delivery surface faces upwards towards the media. 900 1, 3, 5, 7, 11, 16, 20 and 24 hours 2011/06/30
Testosterone Buccal Tablet (Extended Release) Develop a dissolution method 2023/09/15
Testosterone Pellet Implant Develop a dissolution method 2008/11/25
Testosterone Undecanoate Capsule II (Paddle) 75 0.01 N HCl with 0.5% Triton X 100 900 5, 10, 15, 30, 45 and 60 2024/02/05
Testosterone Undecanoate Capsule II (Paddle) 75 Phosphate buffer pH 6.8 with 1.0% Triton X-100 900 10, 15, 20, 30 and 45 2021/08/19
Tetrabenazine Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 30 and 45 2011/09/01
Tetracycline HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Tetracycline HCl Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
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

数据库说明:

当前数据更新日期:2025年01月10日。
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