FDA溶出度方法库(AI中文)2730条
药品名称
剂型
USP溶出方法
转速（转/min）
溶出介质
容积
荐采样时间
更新时间
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
01/26/2012
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
01/03/2007
Metformin HCl
Tablet (Extended Release)
Refer to USP
12/12/2008
Metformin HCl
Tablet
Refer to FDA's Dissolution Guidance, 2018
07/02/2020
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
01/30/2020
Metaxalone
Tablet
Refer to USP
10/20/2016
Mestranol/Norethindrone
Tablet
Refer to USP
03/25/2010
Mesna
Tablet
II (Paddle)
50
0.06 N HCl
500
5, 10, 15, 20 and 30
02/09/2004
Mesalamine Enema
Rectal Enema
II (Paddle)
50
Phosphate Buffer, pH 7.2
900
5, 10, 15, and 30
06/18/2007
Mesalamine (400 mg and 800 mg)
Tablet (Delayed Release)
Refer to USP
11/05/2010
Mesalamine (375 mg)
Capsule (Extended Release)
I (Basket)
100
Acid Stage: 0.1N HCl Buffer stage: Phosphate Buffer, pH 6.8
Acid stage: 2 hours; Buffer stage: 0.5, 1, 2, 4, 7 and 9 hours
06/10/2009
Mesalamine (250 mg and 500 mg)
Capsule (Extended Release)
Refer to USP
06/10/2009
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): 2 hours; Buffer stage (B): 1 hour; Buffer stage (C): 1, 2, 4, 6 and 8 hours
06/10/2009
Mesalamine
Suppository
II (Paddle) with option to use a sinker
For 500 mg strength: 0.2 M Phosphate buffer, pH 7.5 at 37 deg. C For 1000 mg strength: 0.2 M Phosphate buffer, pH 7.5 at 40 deg. C
900
30, 60, 90, 120 and 150
01/30/2006
Mesalamine
Capsule (Delayed Release)
II (Paddle)
Phase 1: 0.1N HCl (degas); Phase 2: pH 6.0 Buffer (degas); Phase 3: pH 7.2 Buffer
Phase 1: 120; Phase 2: 60; Phase 3: 20, 30, 45, 60, 75, 90 and 120
06/30/2016
Mercaptopurine
Oral Suspension
II (Paddle)
50
0.1N HCl
900
5, 10, 15, 20 and 30
12/24/2015
Mercaptopurine
Tablet
II (Paddle)
50
0.1 N HCl
900
20, 30, 45, 60, 90 and 120
02/06/2004
Meprobamate
Tablet
Refer to FDA's Dissolution Guidance, 2018
07/02/2020
Meprobamate
Tablet
Refer to USP
11/25/2008
薄荷醇/水杨酸甲酯
局部贴剂
VI（汽缸）
50
Neutralized phthalate buffered solution (0.2 M potassium biphthalate) with pH of 5.0 at 32 ± 0.5°C
900
10, 20, 30, 60, 120, 150 and 180
01/31/2013