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
Demeclocycline HCl Tablet Develop a dissolution method 2024/01/03
Desipramine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Desloratadine Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Desloratadine Tablet (Orally Disintegrating) II (Paddle) 50 0.1 N HCl 900 3, 6, 10, 15 2007/06/18
Desloratadine/Pseudoephedrine Sulfate (2.5 mg/120 mg) Tablet (Extended Release) II (Paddle) 50 First hour: 0.1 N HCl; After 1 hour: 0.1M Potassium Phosphate Buffer pH 7.5 1000 For Desloratadine: 10, 20, 30 and 45; For Pseudoephedrine Sulfate: 1, 2, 6 and 8 hours 2009/04/02
Desloratadine/Pseudoephedrine Sulfate (5 mg/240 mg) Tablet (Extended Release) II (Paddle) 50 First hour: 0.1 N HCl; After 1 hour: 0.1M Potassium Phosphate Buffer pH 7.5 1000 For Desloratadine: 10, 20, 30 and 45; For Pseudoephedrine Sulfate: 1, 2, 4, 8, 16 and 24 hours 2009/04/02
Desmopressin Acetate Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Desogestrel/Ethinyl Estradiol Tablet Refer to USP 2008/11/04
Desvenlafaxine Succinate Tablet (Extended Release) Develop a dissolution method 2023/09/15
Deucravacitinib Tablet II (Paddle) 75 50 mM potassium phosphate buffer, pH 6.3 with 0.01% (w/v) Brij®35 1000 10, 20, 30, 45 and 60 2023/11/30
Deuruxoutinib Phosphate Tablet Refer to FDA's Dissolution Guidance, 2018 2026/01/28
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
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
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 Insert Develop a method to characterize in vitro release 2026/03/25
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

数据库说明:

当前数据更新日期:2026年04月20日。
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