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
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 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
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
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
Doxycycline Hyclate ( 150 mg and 75 mg) Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Doxycycline Hyclate ( 200 mg, 150 mg, 100 mg, 80 mg and 75 mg) Tablet (Delayed Release) Refer to USP 2015/05/28
Doxycycline Hyclate ( 50 mg) Tablet (Delayed Release) I (Basket) 100 Acid stage: 0.06 N HCl; Buffer stage: Neutralized Phthalate Buffer, pH 5.5 900 Acid stage: 5, 10, 15, 20 and 30; Buffer stage: 5, 10, 15, 20 and 30 2015/05/28
Doxylamine Succinate/Pyridoxine HCl Tablet (Extended Release) II (Paddle) 100 Acid stage: 0.1 N HCl: Buffer stage: 0.2M sodium phosphate buffer pH 6.8 Acid stage: 1000 mL; Buffer stage: 1000 mL Acid stage: 5, 10, 15, 30, 60, 120; Buffer stage: 5, 10, 15, 20 and 30 2017/01/19
Dronabinol Capsule Develop a dissolution method; (In addition, the USP capsule rupture test should also be conducted) 2023/09/15
Dronedarone HCl Tablet II (Paddle) with sinker 75 pH 4.5 Phosphate buffer 1000 10, 15, 20, 30, 45, 60, 90 and 120 2015/02/25
Drospirenone/Estetrol Tablet II (Paddle) 50 Phosphate Buffer pH 6.8 900 5,10, 15, 20 and 30 2023/03/30

数据库说明:

当前数据更新日期:2025年12月13日。
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