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
Deutetrabenazine Tablet II (Paddle) over a disk (62 mm with 16 mesh) 75 pH 3.0 Acid Phthalate Buffer 500 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours 2017/11/02
Deutetrabenazine Tablet, Extended Release II (Paddle) with sinker 75 50 mM Potassium Biphthalate pH 3.0 500 1, 2, 4, 6, 8, 10, 12, 16 and 20 hours 2025/06/23
Deutivacaftor (Deu); Tezacaftor (Tez); Vanzacaftor Calcium (Van) Tablet II (Paddle) 75 Van and Deu: 0.5% (w/v) SLS in 50 mM sodium phosphate, pH 6.8; Tez: 0.2% (w/v) SLS solution in 0.1 N HCl 900 5, 10, 15, 20, 30, 45, 60 and 75 2026/01/28
Dexamethasone Implant (Intravitreal) VII (with reciprocating 50 mesh baskets) 30 cycles per min Phosphate Buffered Saline containing 0.05 g/L sodium dodecyl sulfate at 45 ± 0.5°C 30 12, 24, 48, 72, 96, 120, 144, 168, 192, 216 and 240 hours 2010/10/21
Dexamethasone Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Dexamethasone/Neomycin Sulfate/ Polymyxin B Sulfate Ophthalmic Suspension Develop a method to characterize in vitro release 2018/02/15
Dexamethasone/Tobramycin Ophthalmic Suspension Develop a method to characterize in vitro release 2009/04/02
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 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
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
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 Develop a dissolution method 2023/09/15
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
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

数据库说明:

当前数据更新日期:2026年02月09日。
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