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
Nadolol
Tablet
Refer to FDA's Dissolution Guidance, 2018
07/02/2020
Nabumetone
Tablet
Refer to USP
07/25/2007
Nabilone
Capsule
II (Paddle)
50
0.1% Tween 80 solution
1000
15, 30, 45 and 60
07/14/2008
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.)
120 (Acid), 10, 20, 30, 45 and 60 (Buffer)
12/19/2008
Mycophenolate Mofetil
Tablet
II (Paddle)
50
0.1 N HCl
900
5, 10, 15 and 30
02/10/2004
Mycophenolate Mofetil
Capsule
II (Paddle)
40
0.1 N HCl
900
5, 10, 20 and 30
02/10/2004
Mycophenolate Mofetil
Suspension
II (Paddle)
40
0.1 N HCl
900
5, 10, 20 and 30
02/10/2004
Moxifloxacin
Tablet
Refer to FDA's Dissolution Guidance, 2018
07/02/2020
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
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.
01/26/2012
Morphine Sulfate (BC)
Tablet (Extended Release)
I (Basket)
100
Water
500
1, 2, 4, 6, 8, 10 and 12 hours
12/23/2010
Morphine Sulfate (AB2)
Capsule (Extended Release)
II (Paddle)
50
Phosphate Buffer, pH 6.8
900
1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hours
08/14/2014
Morphine Sulfate (AB)
Tablet (Extended Release)
I (Basket)
50
Water (deaerated)
900
1, 2, 3, 6, 9 and 12 hours
12/23/2010
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
10/20/2016
Morphine Sulfate
Capsule (Extended Release)
Refer to USP
08/11/2008
Morphine Sulfate
Tablet
Refer to FDA's Dissolution Guidance, 2018
07/02/2020
Montelukast Sodium
Tablet (Chewable)
II (Paddle)
50
0.5% SDS in water
900
5, 10, 20 and 30
03/04/2006
Montelukast Sodium
Tablet
II (Paddle)
50
0.5% SDS in water
900
5, 10, 20 and 30
04/09/2007
Montelukast
Granule
I (Basket) (100 mesh)
50
0.5% w/v SDS in Water
900
5, 15, 20 and 30
09/24/2008
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
08/27/2020
Molindone HCl
Tablet
Refer to FDA's Dissolution Guidance, 2018
07/02/2020