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
Elacestrant Dihydrochloride Tablet II (Paddle) 75 0.01 N HCl 500 for 100 mg; 1000 for 400 mg 5, 10, 15, 30, 45 and 60 2024/05/31
Elafibranor Tablet II (Paddle) 50 0.1% sodium dodecyl sulfate (SDS) in phosphate buffer, pH 6.8 900 10, 15, 20, 30, 45 and 60 2026/01/28
Elagolix Sodium Tablet II (Paddle) 50 0.05 M Sodium Phosphate, pH 6.8 900 5, 10, 15, 20, 30 and 45 2021/04/22
Elagolix Sodium, Estradiol, Norethindrone Acetate; Elagolix Sodium Capsule Elagolix: I (Basket) Elagolix: 100 Elagolix: 0.05M Sodium Phosphate pH 6.8 10, 15, 20, 25, 30, 45, 60 and 90 2024/02/05
Elbasvir/Grazoprevir Tablet I (Basket) 100 Phosphate Buffer, pH 6.8 with 0.45% (w/v) Polysorbate 80 900 10, 15, 20, 30, 45 and 60 2016/07/28
Eletriptan Hydrobromide Tablet I (Basket) 100 0.1 N HCl 900 5, 10, 15 and 30 2009/04/02
Elexacaftor (Ele); Ivacaftor (Iva); Tezacaftor (Tez) GRANULES II (Paddle) 65 Ele: 1.8% (v/v) Tween 20 in 50 mM sodium phosphate, pH 6.8 Tez: 0.1% (w/v) SLS in 0.1 N HCl Iva: 0.4% (w/v) SLS in 50 mM sodium phosphate buffer, pH 6.8 900 5, 10, 15, 20, 30, 45, 60 and 75 2026/01/28
Elexacaftor, Ivacaftor, Tezacaftor [FDC:ELE+ IVA+ TEZ]; Ivacaftor [IVA] Tablet/Tablet (Copackage) II (Paddle) FDC: ELE: 75/IVA: 65/TEZ:75; IVA: 75 FDA: ELE: 1.8% (v/v) Polysorbate 20 in 50 mM sodium phosphate, pH 6.8/ IVA: 0.4% (w/v) SLS in 50 mM sodium phosphate, pH 6.8/TEZ: 0.2% (w/v) SLS solution in 0.1N HCl; IVA: 1.8% (v/v) Polysorbate 20 in 50 mM sodium phosphate, pH 6.8 FDC: ELE: 900/IVA: 900/TEZ:900; IVA 900 5, 10, 15, 20 and 30 2021/08/19
Eliglustat Tartrate Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Eltrombopag Choline Tablet II (Paddle) 75 0.25% Tween 80 in 0.05 M pH 6.8 Potassium Phosphate Buffer, pH 6.8 900 5, 10, 15, 20, 30, 45 and 60 2026/01/28
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

数据库说明:

当前数据更新日期:2026年02月09日。
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