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
Dexbrompheniramine Maleate/Pseudoephedrine Sulfate Tablet (Extended Release) III (Reciprocating Cylinder) 12 dpm 0.02N HCl (2 hours) followed by 0.05M Phosphate Buffer pH 7.5 250 0.5, 1, 2, 3, 4, 6 and 8 hours 2015/05/28
Dexlansoprazole Tablet (Delayed Release, Orally Disintegrating) I (Basket -100 mesh) 100 Acid Stage: 0.1 N HCl; Buffer Stage: pH 7.2 Phosphate Buffer with 5 mM Sodium lauryl sulfate Acid Stage: 500 mL; Buffer Stage: 900 mL Acid Stage: 120; Buffer Stage: 10, 15, 20, 30, 50, 60, 75 and 90 2016/07/28
Dexlansoprazole Capsule (Delayed Release) I (Basket) 100 Acid Stage: 0.1 N HCl, Buffer Stage: pH 7.0 Phosphate Buffer with 5 mM SLS Acid Stage: 500; Buffer stage: 900 Acid Stage: 120; Buffer Stage: 10, 20, 40, 50, 60 , 75, 105 and 120 2010/08/05
Dexmedetomidine HCl Sublingual Film V (Paddle over disk) 50 Simulated saliva 500 5, 10, 15, 20 and 30 2023/05/31
Dexmethylphenidate HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Dexmethylphenidate HCl Capsule (Extended Release) I (Basket) 100 First 2 hours: 0.01 N HCl, Hours 2-10: Phosphate Buffer, pH 6.8 Acid: 500, Buffer: 500 0.5, 1, 2, 4, 6, and 10 hours 2008/01/14
Dexmethylphenidate HCl; Serdexmethylphenidate Chloride Capsule Refer to FDA's Dissolution Guidance, 2018 2023/05/18
Dextroamphetamine Transdermal System VI (Cylinder) 50 50 mM potassium phosphate buffer, pH 6.8 5, 10, 15, 30, 45, 60, 120, 180, 240, 300 and 360 2023/11/30
Dextroamphetamine Sulfate Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Dextroamphetamine Sulfate Capsule (Extended Release) I ( Basket) 100 0.1 N HCl 500 1, 4, 8 and 12 hours 2008/11/25
Dextroamphetamine Sulfate Tablet Develop a dissolution method 2023/09/15
Dextromethophan HBr/Guaifenesin Tablet (Extended Release) I (Basket) 50 0.01 N HCl 900 1, 2, 6, and 12 hours 2008/11/25
Dextromethorphan Hydrobromide/Quinidine Sulfate Capsule I (Basket) 100 pH 1.2, Simulated Gastric Fluid without enzyme 900 5, 10, 15, 20 and 30 2012/01/05
Dextromethorphan Polistirex Suspension (Extended Release) II (Paddle) 50 0.1 N HCl 500 30, 60, 90 and 180 2008/10/06
Diazepam Film Develop a dissolution method 2025/06/23
Diazepam Tablet Refer to USP 2007/07/25
Diazoxide Oral suspension Develop a dissolution method 2014/02/14
Diclofenac Capsule I (Basket) 100 10 mM Citrate Buffer pH 5.5 with 0.05% Sodium Dodecyl Sulfate (SDS) 900 5, 10, 20, 30 and 45 2015/06/25
Diclofenac Epolamine Topical patch V (Paddle over Disk) with a watchdish (a diameter of 6 cm) 50 pH 6.8 phosphate buffer at 32 ± 0.5°C 500 15, 30, 45, 60, 90, 120 and 180 2010/10/21
Diclofenac Potassium Powder for Oral Solution II (Paddle 75 0.05M phosphate buffer (TriSodium Phosphate Dodecahydrate in 0.1 N HCl and pH adjusted to 6.8) 400 2.5, 5, 7.5 and 10 2010/10/21

数据库说明:

当前数据更新日期:2025年12月08日。
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