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
Dapagliflozin Propanediol/ Metformin HCl Tablet (Extended Release) I (Basket- 20 mesh) 100 Phosphate Buffer, pH 6.8 1000 Dapagliflozin: 5, 10, 15, 20, 30 and 45 minutes: Metaformin: 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours 2015/08/27
Dapagliflozin/Saxagliptin HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2020/08/27
Daprodustat Tablet II (Paddle) 50 30 mM Phosphate Buffer, pH 6.8 500 for 1 mg; 900 for 2, 4, 6 and 8 mg 5, 10, 15, 20, 25, 30, 45 and 60 2024/05/31
Dapsone Tablet Refer to USP 2010/12/23
Dapsone Gel (Topical) Develop a method to characterize in vitro release 2016/07/28
Daridorexant HCl Tablet II (Paddle) 75 pH 1.2 (NaCl/HCl) 900 5, 10, 15 and 30 2023/05/18
Darifenacin Hydrobromide Tablet (Extended Release) I (Basket) 100 0.01N HCl 900 1, 4, 8, 12, 16, 20 and 24 hours 2006/01/20
Darolutamide Tablet II (Paddle) 75 1% sodium lauryl sulfate (SLS) in 0.01N HCl 1000 15, 30, 45, 60, 75 and 90 2020/01/30
Darunavir Ethanolate Oral Suspension II (Paddle) 75 0.05% Polysorbate 20 in 0.05M Phosphate Buffer, pH 6.8 900 5, 10, 15, 20, 30 and 45 2015/06/25
Darunavir Ethanolate Tablet II (Paddle) 75 2% Tween-20 in 0.05 M Sodium Phosphate Buffer, pH 3.0 900 10, 20, 30, and 45 2007/09/13
Darunavir(Drv)/Cobicistat (Cobi)/Emtricitabine (Emt)/Tenofovir Alafenamide Fumarate (Taf) Tablet II (Paddle) 75 Drv: 0.05 M Sodium Phosphate Buffer, pH 3.0, 2% Tween 20; For Cobi, Emt and Taf: Citrate Phosphate Buffer, pH 4.2 900 Drv: 10, 15, 20, 30 and 45; For Cobi, Emt and Taf: 5, 10, 15, 20 and 30 2022/07/07
Dasabuvir Na/ Ombitasvir/Paritaprevir/Ritonavir Tablet (Extended Release) III (Reciprocating Cylinder [40 mesh (for bottom and top of the inner tube)] 25 dpm 15 mM hexadecyltrimethylammonium bromide (CTAB) in 0.03M Sodium Phosphate Buffer, pH 6.8 250 Ombitasvir/ Paritaprevir/ Ritonavir: 10, 15, 20, 30, 45, 60 and 90 minutes;Dasabuvir: 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24 hours 2016/10/20
Dasatinib Tablet II (Paddle) 60 pH 4.0 Acetate buffer containing 1% Triton X-100 1000 10, 15, 30 and 45 2009/10/30
Deferasirox Tablet II (Paddle) 75 0.5% Tween 20 in Phosphate Buffer, pH 6.8 900 5, 10, 15, 20 and 30 2016/03/17
Deferasirox Tablet (for Oral Suspension) II (Paddle) 50 Phosphate buffer pH 6.8 with 0.5% Tween 20 900 10, 20, 30 and 45 2006/06/21
Deferasirox Granule II (Paddle) 75 Phosphate Buffer, pH 6.8 with 0.5% Tween 20 900 5, 10, 15, 20 and 30 2017/11/02
Deferiprone Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Deferiprone (1 GM) Tablet I (Basket) 100 Acidic Stage: 0.1 N HCl, Buffer Stage: 0.05 M Phosphate buffer, pH 6.8. Acid Stage: 2 hours; Buffer Stage: 1, 2, 3 and 4 hours 2022/07/07
Deflazacort Suspension II (Paddle) 25 Simulated Gastric Fluid, pH 1.2 500 5, 10, 15 and 30 2023/07/07
Deflazacort Tablet II (Paddle) 50 50 mM Phosphate buffer w/0.3% SLS, pH 6.8 500 5, ,15, 30 and 45 2023/07/07

数据库说明:

当前数据更新日期:2025年12月08日。
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