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
Gilteritinib Fumarate Tablet II (Paddle) 50 0.1 N HCl 900 10, 15, 20, 30 and 45 2020/08/27
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
Glipizide Tablet Refer to USP 2010/08/05
Glipizide/Metformin HCL Tablet Refer to USP 2008/12/18
Glyburide (Micronized) Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 7.5 900 10, 20, 30, 45 and 60 2004/02/02
Glyburide (Non-micronized) Tablet II (Paddle) 75 0.05 M Borate Buffer, pH 9.5 500 10, 20, 30, 45 and 60 2004/02/02
Glyburide/Metformin HCl Tablet Refer to USP 2008/01/14
Glycopyrrolate Tablet, Oral Disintegrating Refer to FDA's Dissolution Guidance, 2018 2025/09/08
Glycopyrrolate Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Goserelin Acetate Implant Prior to sampling, the jar is removed from incubation and mechanically swirled with digital orbital shaker Swirl orbit of 50 mm at 205 rpm for 6 seconds Each implant should be incubated in 50 mL of phosphate buffered saline, pH 7.4, at 39°C (warmed overnight before the implants are added), in a 120-mL Wheaton jar. 50 3, 14, 35, 56 and 84 days (10.8 mg strength); 7, 14, 17, 21 and 28 days (3.6 mg strength) 2008/11/04
Granisetron Injectable (Extended Release) Develop a method to characterize in vitro release 2016/12/22
Granisetron Film, Transdermal (Extended Release) VI (Cylinder) 50 80 microL /L phosphoric acid (85%) at 32 ± 0.5°C 1000 2, 6, 12, 24, 36, 48, 60, 72 and 96 hours 2011/03/03
Granisetron HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Griseofulvin Oral Suspension Develop a dissolution method 2023/09/15
Griseofulvin (Microcrystalline) Oral Suspension Develop a dissolution method 2023/09/15
Griseofulvin (Microcrystalline) Tablet Develop a dissolution method 2024/01/03
Griseofulvin (Ultramicrocrystalline) Tablet Develop a dissolution method 2024/01/03

数据库说明:

当前数据更新日期:2025年12月17日。
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