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
Dolutegravir Sodium (50 mg) Tablet II (Paddle) 50 0.01M pH 6.8 phosphate buffer containing 0.25% w/v sodium dodecyl sulfate (SDS) 900 5, 10, 15, 20, 30 and 45 2018/10/18
Donepezil HCl/Memantine HCl Capsule (Extended Release) I (Basket) 100 pH 1.2 NaCl/HCl buffer 900 Donepezil: 5, 10, 15, 20 and 30 minutes; Memantine: 1, 2, 3, 4, 6, 8, 10 and 12 hours 2015/05/28
Donepezil HCl Tablet (Orally Disintegrating (ODT)) II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 2006/03/04
Donepezil HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Donepezil HCl Transdermal V (Paddle over disk) with Transdermal System Holding Wire Screen (TSHWR) 100 0.02 M sodium acetate buffer, pH 4.5 at 32°C 900 1,8,24,48 and 168 hours 2023/05/18
Donepezil HCl (23 mg) Tablet II (Paddle 50 0.05 M Phosphate Buffer, pH 6.8 900 1, 2, 3, 4, 6, 8 and 10 hours 2010/12/23
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate Tablets II (Paddle) 75 25 mM Phosphate Buffer, pH 6.8 with 3% Polysorbate 80 900 5, 10, 15, 20, 30, 45, 60 and 90 2023/10/06
Doxazosin Mesylate Tablet II (Paddle) 50 0.01 N HCl 900 10, 20, 30, 45 and 60 2004/01/27
Doxazosin Mesylate Tablet (Extended Release) II (Paddle) 75 SGF without enzyme 900 1, 2, 4, 6, 8, 12 and 16 hours 2007/01/03
Doxepin HCl Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Doxepin HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Doxepin HCl Tablet II (Paddle) 50 Simulated Gastric Fluid w/o enzyme (pH 1.1-1.3) 900 5, 10, 15, 20, 30 and 45 2010/09/02
Doxercalciferol Capsule Develop a quantitative rupture test 2008/06/03
Doxorubicin HCl Injectable (Liposomal) Develop a method to characterize in vitro release, starting at pH 6.00 ± 0.05 and at 47ºC ± 0.5ºC. Replicate for 12 dosage vials. 2012/10/04
Doxycycline Capsule (Delayed Release) II (Paddle) 75 Dilute HCl, pH 1.1 for 2 hours and then add 200 mL of 0.1 N NaOH in 200 mM Phosphate Buffer. Adjust pH to 6.0 using 2 N HCl and/or 2N NaOH Acid stage: 750; Buffer stage: 950 1, 2, 2.5 , 3 and 4 hours 2008/10/06
Doxycycline Suspension II (Paddle) 25 0.01 N HCl 900 5, 10, 15 and 20 2008/09/03
Doxycycline Calcium Suspension Develop a dissolution method 2019/03/07
Doxycycline Hyclate Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Doxycycline Hyclate Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Doxycycline Hyclate ( 120 mg and 60 mg) Tablet (Delayed Release) I (Basket) 100 Acid stage: 0.06 N HCl; Buffer stage: Neutralized Phthalate Buffer, pH 5.5 Acid stage: 900 mL; Buffer stage: 900 mL Acid stage: 10, 20, 30, 45 and 60; Buffer stage: 5, 10, 15, 20, 30 and 45 2018/03/27

数据库说明:

当前数据更新日期:2026年02月09日。
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