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
Eltrombopag Olamine Tablet II (Paddle) 50 0.5% Polysorbate 80 in Phosphate Buffer, pH 6.8 900 10, 15, 20, 30, 45, and 60 2012/06/07
Eltrombopag Olamine Suspension II (Paddle) 50 50 mM potassium phosphate in water, pH 6.8 with 0.2% polysorbate 80 750 4, 8, 12, 15 and 20 2016/10/20
Eluxadoline Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Elvitegravir Tablet II (Paddle) with sinker 75 2.0% w/v Polysorbate 80 in 0.01 N HCl (pH 2.0) at 37 ºC 700 mL for 85 mg tablets; 1000 mL for 150 mg tablets 1000 mL for 150 mg tablets 10, 20, 30, 45 and 60 2015/12/24
Empagliflozin Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Empagliflozin/ Metformin HCl Tablet (Extended Release) I (Basket) 100 Phosphate Buffer, pH 6.8 900 Metformin: 1, 2, 4, 6, 8, 10 and 12 hours: Empagliflozin: 10, 15, 20, 30, 45 and 60 minutes; 2017/01/19
Empagliflozin/Linagliptin Tablet II (Paddle) 50 pH 6.8 Phosphate Buffer 900 10, 15, 20, 30 and 45 2015/12/24
Empagliflozin/Linagliptin/Metformin HCl Tablet (Extended Release) I (Basket) 100 Phosphate Buffer, pH 6.8 900 Metformin: 1, 2, 4, 6, 8, 10 and 12 hours: Empagliflozin and Linagliptin: 10, 15, 20, 30, 45 and 60 minutes 2020/04/02
Empagliflozin/Metformin HCl Tablet II (Paddle) 50 Phosphate Buffer, pH 6.8 (degas) 900 5, 10, 15, 20 and 30 2016/06/30
Emtricitabine Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
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
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

数据库说明:

当前数据更新日期:2025年12月14日。
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