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
Imatinib Mesylate Tablet II (Paddle) 50 0.1 N HCl 1000 5, 10, 15, 20 and 30 2011/09/22
Imipramine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Imipramine Pamoate Capsule I (Basket) 100 0.1 N HCl without pepsin and with 0.3% pepsin (addition of pepsin is recommended only when significant slow dissolution is observed) 900 30, 60, 90, 120, 150 and 180 2008/01/14
Inavolisib Tablet II (Paddle) 50 0.1 N HCl 5, 10, 15, 20, 30, 45 and 60 2026/01/28
Indapamide Tablet Refer to USP 2008/04/15
Indinavir Sulfate Capsule II (Paddle) 50 0.1 M Citrate Buffer, pH 3.8 900 10, 15, 20 and 30 2004/02/04
Indomethacin Suspension Refer to USP 2024/05/31
Indomethacin Rectal Suppository Refer to USP 2021/08/26
Indomethacin Capsule (Extended Release) Refer to USP 2007/07/25
Indomethacin (40 mg and 20 mg) Capsule I (Basket) 100 10 mM citric acid buffer, pH 5.75 750 5, 10, 15, 20 and 30 2015/05/28
Indomethacin (50 and 25 mg) Capsule Refer to USP 2015/05/28
Infigratinib Phosphate Capsule I (Basket) 100 0.01 N HCl 900 15, 30, 45 and 60 2023/05/18
Iptacopan Hydrochloride Capsule Refer to FDA's Dissolution Guidance, 2018 2025/06/23
Irbesartan Tablet Refer to USP 2008/08/11
Isavuconazonium Sulfate Capsule II (Paddle) with sinker 75 Diluted McIlvaine Buffer [12.5 mM disodium hydrogen phosphate solution +6.25 mM citric acid solution ] + 0.5 % Sodium Lauryl sulfate (SLS) 900 10, 20, 30, 45, 60, 75 and 90 2016/03/17
Isocarboxazid Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30, 45 and 60 2004/02/04
Isoniazid Tablet Refer to USP 2008/04/15
Isosorbide Dinitrate Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Isosorbide Dinitrate Capsule (Extended Release) Refer to USP 2015/06/25
Isosorbide Dinitrate Tablet (Extended Release) Develop a dissolution method 2024/01/03

数据库说明:

当前数据更新日期:2026年06月14日。
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