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
Emtricitabine/Rilpivirine HCl/Tenofovir Alafenamide Fumarate Tablet II (Paddle 75 Rilpivirine (RPV): 0.5% Polysorbate 20 in 0.01 N HCl; Emtricitabine (ETC) and Tenofovir alafenamide (TAF): 50 mM Sodium Citrate, pH 5.5, RPV: 1000 mL; ETC and TAF: 500 mL 5, 10, 15, 20, 30 and 45 2016/07/28
Emtricitabine/Rilpivirine HCl/Tenofovir Disoproxil Fumarate Tablet II (Paddle) with sinker 75 0.5%(w/w) polysorbate 20 in 0.01N HCl (pH 2.0) 1000 Emtricitabine and Tenofovir: 5, 10, 15, 20 and 30; Rilpivirine: 10, 20, 30, 45, 60, 75, 90 and 120 2015/01/15
Emtricitabine/Tenofovir Alafenamide Fumarate Tablet II (Paddle 75 50 mM Sodium Citrate buffer, pH 5.5 500 5, 10, 15, 20, 30 and 45 2016/07/28
Emtricitabine/Tenofovir Disoproxil Fumarate Tablet II (Paddle) 50 0.01 N HCl 900 5, 10, 15, 30 and 45 2007/01/03
Enalapril Maleate Tablet Refer to USP 2008/09/03
Encorafenib Capsule II (Paddle) with sinker 100 Ammonium acetate buffer, pH 4.5 900 15, 30, 45 and 60 2025/03/17
Ensartinib Hydrochloride Capsule II (Paddle) with sinker 50 0.1 N HCl 900 15, 20, 30, 45 and 60 2026/01/28
Entacapone Tablet II (Paddle) 50 Phosphate Buffer, pH 5.5 900 10, 20, 30 and 45 2004/01/29
Entecavir Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Entrectinib Capsule II (Paddle) with Sinker 75 50 mM Potassium Phosphate, pH 6.0 with 0.374% w/v polysorbate 80 1000 15, 20, 30, 45, 60 and 75 2021/08/19
Enzalutamide Tablet II (Paddle) 50 Phosphate Buffer, pH 7.5 900 5, 10, 15, 20, 30 and 45 2022/05/12
Enzalutamide Capsule II (Paddle) with sinker 50 Tier 1 Medium: 0.3% cetyl trimethyl ammonium bromide (CTAB) in 0.1 N HCl;Tier 2 Medium: 0.3% CTAB in 0.1 N HCl containing Pepsin 600,000 USP units/L. 900 10, 15, 20, 30 and 45 2015/05/28
Eplerenone Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Eprosartan Mesylate Tablet II (Paddle) 75 0.2 M Phosphate Buffer, pH 7.5 1000 15, 30, 45 and 60 2008/07/14
Eprosartan Mesylate/Hydrochlorothiazide Tablet II (Paddle) 75 0.2 M Phosphate Buffer, pH 7.5 1000 10, 20, 30 and 45 2008/02/19
Erdafitinib Tablet I (Basket) 75 0.01 N HCl, pH 2 500 5, 10, 15, 20, 30, 45 and 60
Ergocalciferol Capsule II (Paddle) 100 0.5 N NaOH with 10% Triton-X-100 500 15, 30, 45, 60 and 90 2010/08/05
Erlotinib HCl Tablet II (Paddle) 75 0.02% Tween 80 in 0.01 N HCl 1000 5, 10, 15, 20, 30 and 45 2018/10/18
Ertugliflozin Tablet Refer to FDA's Dissolution Guidance, 2018 2025/06/23
Erythromycin Tablet Refer to USP 2015/12/24

数据库说明:

当前数据更新日期:2026年02月09日。
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