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
Diltiazem HCl Tablet (Extended Release) II (Paddle) 100 Phosphate Buffer, pH 5.8 900 2, 8, 14, and 24 hours 2008/02/19
Diltiazem HCl Capsule (Extended Release) Develop a dissolution method 2024/01/03
Dimethyl Fumarate Capsule  (Delayed Release) II (Paddle) 100 Acid stage: 0.1 N HCl; Buffer stage: pH 6.8 Phosphate Buffer Acid stage: 500; Buffer stage: 500 Acid stage: 2 hours; Buffer stage: 5, 10, 20, 30 and 45 2016/06/02
Dinoprostone Vaginal Insert (Extended Release) Develop a dissolution method 2023/09/15
Dinoprostone Vaginal Suppository Develop a method to characterize in vitro release 2012/10/04
Diphenhydramine Citrate/Ibuprofen Tablet II (Paddle) 50 50 mM Phosphate Buffer, pH 6.5 900 10, 20, 30 and 45 2008/01/14
Diphenhydramine HCl/Ibuprofen Capsule I (Basket) 100 200 mM Phosphate Buffer, pH 7.2 900 10, 20, 30 and 45 2008/01/14
Dipyridamole Tablet Refer to USP 2007/06/18
Diroximel Fumarate Capsule (Delayed Release) II (Paddle) with sinker 75 Acid Stage: 0.1 N HCl; Buffer Stage: Na.Phosphate Buffer, pH 6.5 Acid Stage: 120; Buffer Stage: 10, 20, 30, 45, 60, 75 and 90 2020/04/02
Disopyramide Phosphate Capsule (Extended Release) Refer to USP 2008/11/04
Disopyramide Phosphate Capsule Develop a dissolution method 2024/01/03
Disulfiram Tablet II (Paddle) 100 2% SDS 900 15, 30, 45, 60, 75, 90, 105, and 120 2007/06/18
Divalproex Sodium Tablet (Delayed Release) Refer to USP 2007/07/25
Divalproex Sodium Tablet (Extended Release) Refer to USP 2016/06/30
Divalproex Sodium Capsule (Delayed Release) Refer to USP 2016/06/30
Dofetilide Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Dolasetron Mesylate Tablet Develop a dissolution method 2024/01/03
Dolutegravir Na/Rilpivirine HCl Tablet II (Paddle) 75 1.0 % Tween 20 in 0.01 M HCl, pH 2.0 900 10, 15, 20, 30, 45 and 60 2018/02/08
Dolutegravir Sodium (10 mg) Tablet II (Paddle) 50 0.01M pH 6.8 phosphate buffer 900 5, 10, 15, 20, 30 and 45 2018/10/18
Dolutegravir Sodium (25 mg) Tablet II (Paddle) 50 0.01M pH 6.8 phosphate buffer containing 0.15% w/v sodium dodecyl sulfate (SDS) 900 5, 10, 15, 20, 30 and 45 2018/10/18

数据库说明:

当前数据更新日期:2026年02月07日。
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