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
Mesalamine (1.2 gram) Tablet (Delayed Release) II (Paddle) 100 Acid stage (A): 100 mM HCl Buffer stage (B): Phosphate Buffer, pH 6.4 Buffer stage (C): Phosphate Buffer, pH 7.2 Acid stage (A): 750 mL; Buffer stage (B): 950 mL; Buffer stage (C): 960 mL Acid stage (A): 2 hours; Buffer stage (B): 1 hour; Buffer stage (C): 1, 2, 4, 6 and 8 hours 2009/06/10
Mesalamine (250 mg and 500 mg) Capsule (Extended Release) Refer to USP 2009/06/10
Mesalamine (375 mg) Capsule (Extended Release) I (Basket) 100 Acid Stage: 0.1N HCl Buffer stage: Phosphate Buffer, pH 6.8 Acid stage: 750 mL; Buffer stage: 1000 mL Acid stage: 2 hours; Buffer stage: 0.5, 1, 2, 4, 7 and 9 hours 2009/06/10
Mesalamine (400 mg and 800 mg) Tablet (Delayed Release) Refer to USP 2010/11/05
Mesalamine Enema Rectal Enema II (Paddle) 50 Phosphate Buffer, pH 7.2 900 5, 10, 15, and 30 2007/06/18
Mesna Tablet II (Paddle) 50 0.06 N HCl 500 5, 10, 15, 20 and 30 2004/02/09
Mestranol/Norethindrone Tablet Refer to USP 2010/03/25
Metaxalone Tablet Develop a dissolution method 2024/01/03
Metformin HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Metformin HCl For Suspension (Extended Release) II (Paddle) 100 Phosphate Buffer, pH 6.8 1000 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours 2020/01/30
Metformin HCl Tablet (Extended Release) Refer to USP 2008/12/12
Metformin HCl (MET); Sitagliptin (SIT) Tablet (Extended Release) II (Paddle) with sinker 75 Phosphate buffer, pH 6.8 900 MET: 1, 2, 3, 4, 6, 8, 10, and 12 hours; SIT: 10, 20, 30, 45 and 60 2023/07/07
Metformin HCl/Pioglitazone HCl Tablet II (Paddle) 50 pH 2.5 McIlvaine buffer (0.1 M Citric acid adjusted to pH 2.5 with 0.2 M Na2HPO4) 900 10, 20, 30 and 45 2007/01/03
Metformin HCl/Saxagliptin Tablet (Extended Release) I (Basket) 100 Phosphate Buffer, pH 6.8 1000 Metformin: 1, 2, 3, 4, 6, 8, 10 and 12 hours. Saxagliptin: 5, 10, 15, 20 and 30 minutes 2012/01/26
Metformin HCl/Sitagliptin Phosphate Tablet II (Paddle) 75 0.025 M NaCl 900 10, 15, 20 and 30 2008/10/06
Metformin/Repaglinide Tablet II (Paddle) 50 Citric acid/phosphate buffer, pH 5.0 900 5, 10, 15, 20 and 30 2009/10/30
Methadone HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Methazolamide Tablet II (Paddle) 100 pH 4.5 Acetate Buffer 900 10, 15, 20, 30 and 45 2015/05/28
Methenamine Hippurate Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Methimazole Tablet Refer to USP 2008/01/14

数据库说明:

当前数据更新日期:2025年12月20日。
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