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
Voxelotor Tablet II (Paddle) 75 50 mM phosphate buffer (pH 6.8) with 2% sodium lauryl sulfate (SLS) 900 5, 10, 20, 30 and 45 2022/07/28
Voxelotor Tablet, for Suspension II (Paddle) 75 50 mM phosphate buffer (pH 6.8) with 2% sodium lauryl sulfate (SLS) 900 5, 10, 15, 20 and 30 2022/07/28
Warfarin Sodium Tablet Develop a dissolution method 2024/01/03
Zafirlukast Tablet II (Paddle) 50 1% w/v Aqueous Sodium Dodecyl Sulfate 1000 10. 30, 30 and 45 2007/10/09
Zalcitabine Tablet Develop a dissolution method 2024/01/03
Zaleplon Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Zidovudine Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Zileuton Tablet Develop a dissolution method 2023/09/15
Zileuton Tablet (Extended Release) Develop a dissolution method 2023/09/15
Zinc Acetate Capsule II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 2004/02/19
Ziprasidone HCl Capsule II (Paddle) 75 Tier I: 0.05 M Na phosphate buffer, pH 7.5 + 2% SDS (w/w) Tier II: 0.05 M Na phosphate buffer, pH 7.5 (700ml) + 1% pancreatin. After 15 min. incubation, add 200 mL of phosphate buffer containg 9% SDS 900 10, 20, 30, 45 and 60 2006/03/04
Zolmitriptan Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Zolmitriptan Tablet (Orally Disintegrating) II (Paddle) 50 0.1 N HCl 500 5, 10, 15, 20 and 30 2007/06/18
Zolpidem Tartrate Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Zolpidem Tartrate Tablet (Extended Release) Refer to USP 2012/01/05
Zolpidem Tartrate (1.75 and 3.5 mg) Tablet (Sublingual) II (Paddle) 50 Simulated intestinal fluid (without enzyme), pH 6.8, (deaerated) 500 1, 3, 5, 7, 10 and 15 2014/08/14
Zolpidem Tartrate (5 and 10 mg) Tablet (Sublingual) II (Paddle) 75 Phosphate Buffer, pH 6.8 900 1, 3, 5, 7, 10 and 15 2014/08/14
Zonisamide Capsule Develop a dissolution method 2023/09/15

数据库说明:

当前数据更新日期:2024年05月08日。
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