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
Molindone HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Momelotinib Tablet II (Paddle) 75 22 mM Sodium Acetate Buffer, pH 4.5 w/1.3% SDS 900 10, 15, 20, 30 and 45 2025/02/24
Monomethyl Fumarate Capsule (Delayed Release) II (Paddle) Stationary Basket over the Paddle 100 Acid Stage: 0.1 N HCl; Buffer Stage: Phosphate buffer, pH 6.8 Acid Stage: 120; Buffer Stage: 15, 30, 45, 60, 90, 120 and 150 2020/08/27
Montelukast Granule Develop a dissolution method 2023/09/15
Montelukast Sodium Tablet (Chewable) Develop a dissolution method 2023/09/15
Montelukast Sodium Tablet Develop a dissolution method 2023/09/15
Morphine Sulfate Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Morphine Sulfate Tablet (Extended Release) I (Basket) 100 Simulated Gastric Fluid [SGF] without enzyme 900 0.25, 0.5, 1, 1.5, 2, 4, 6 and 8 hours 2016/10/20
Morphine Sulfate Capsule (Extended Release) Refer to USP 2008/08/11
Morphine Sulfate/Naltrexone HCl Capsule (Extended Release) II (Paddle) 50 Acid stage: 0.1 N HCl; Buffer stage: 0.05 Phosphate Buffer, pH 7.5 Acid stage: 500; Buffer stage: 500 Morphine Sulfate: Acid stage: 1 hour; Buffer stage: 1, 3, 5, 8 and 10 hours. Naltrexone HCl: Acid stage: 1 hour; Buffer stage: 1, 12, 24, 48, 73 and 96 hours. 2012/01/26
Moxifloxacin Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Mycophenolate Mofetil Suspension II (Paddle) 40 0.1 N HCl 900 5, 10, 20 and 30 2004/02/10
Mycophenolate Mofetil Capsule II (Paddle) 40 0.1 N HCl 900 5, 10, 20 and 30 2004/02/10
Mycophenolate Mofetil Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15 and 30 2004/02/10
Mycophenolic acid Tablet (Delayed Release) II (Paddle) 50 Acid Stage: 0.1 N HCl; Buffer Stage: Buffer Solution, pH 6.8 (After initial 120 mins., 250 mL of 0.2 M sodium phosphate solution is added to acid stage medium. The pH of the mixture is adjusted to 6.8 using 0.2 M sodium phosphate, 2 N sodium hydroxide, or concentrated HCl acid solution if necessary.) 750 (Acid), 1000 (Buffer) 120 (Acid), 10, 20, 30, 45 and 60 (Buffer) 2008/12/19
Nabilone Capsule II (Paddle) 50 0.1% Tween 80 solution 1000 15, 30, 45 and 60 2008/07/14
Nabumetone Tablet Develop a dissolution method 2024/01/03
Nadolol Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Naldemedine Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Naloxegol Oxalate Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02

数据库说明:

当前数据更新日期:2025年12月20日。
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