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
Futibatinib Tablet II (Paddle) 50 50 mM phosphate dihydrogen phosphate buffer, pH 6.8 with 0.5% Tween 80 900 5, 10, 15, 30, 45, 60 and 75 2023/11/30
Gabapentin Tablet I (Basket) 100 Modified simulated gastric fluid (SGF) 900 1, 2, 4, 6, 8, 10, 12, 14 and 16 hours 2023/11/30
Gabapentin Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Gabapentin Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Gabapentin Enacarbil Tablet (Extended Release) II (Paddle) 50 10 mM Phosphate buffer at pH 7.4 with 1.0 % SLS 500 (for 300 mg); 900 (for 600 mg) 0.5, 1, 2, 4, 6, 8, 12 and 24 hours 2013/01/31
Galantamine HBr Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Galantamine HBr Capsule (Extended Release) II (Paddle) 50 50 mM potassium dihydrogen phosphate buffer pH 6.5 900 1, 4, 10 and 12 hours 2006/01/20
Ganaxolone Suspension II (Paddle) 25 2.8% SDS 900 2.5, 5, 7.5, 10, 15, 20 and 30 2023/11/30
Ganciclovir Capsule Develop a dissolution method 2023/09/15
Gefitinib Tablet Develop a dissolution method 2023/09/15
Gemfibrozil Tablet Refer to USP 2007/07/25
Gemifloxacin Mesylate Tablet II (Paddle) 50 0.01 N HCl 900 10, 20, 30 and 45 2007/01/03
Gepirone Hydrochloride Tablet, Extended Release II (Paddle) 50 0.01 N HCl 900 1, 2, 4, 8, 10, 12, 14, 16, 18 and 20 hours 2025/06/23
Gepotidacin Mesylate Tablet II (Paddle) 75 0.1 N HCl 500 5, 10, 15, 20, 25, 30 and 45 2026/01/28
Gilteritinib Fumarate Tablet II (Paddle) 50 0.1 N HCl 900 10, 15, 20, 30 and 45 2020/08/27
Givinostat Hydrochloride Suspension II (Paddle) 30 Phosphate Buffer, pH 4.5 500 5, 10, 15, 20, 30, 45 and 60 2026/01/28
Glimepiride Tablet II (Paddle) 75 Phosphate Buffer, pH 7.8 900 5, 10, 15 and 30 2004/07/23
Glimepiride/Pioglitazone HCl Tablet II (Paddle) 75 For Pioglitazone: pH 2.0, HCl Buffer. For Glimepiride: pH 6.8, Sodium Phosphate Buffer with 0.2% sodium dodecyl sulfate 900 For Pioglitazone: 10, 15, 20, 30 and 45; For Glimepiride: 10, 15, 20 and 30 2009/04/02
Glimepiride/Rosiglitazone Maleate Tablet II (Paddle) 75 0.01 M HCl with 0.5% Sodium Dodecyl Sulfate 900 5, 10, 15, 30, 45 and 60 2007/01/03
Glipizide Tablet (Extended Release) II (Paddle) 50 Simulated Intestinal Fluid without pancreatin, pH 7.5 900 1, 2, 4, 8, 16 hours and until at least 80% dissolved 2008/04/10

数据库说明:

当前数据更新日期:2026年02月09日。
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