FDA溶出度方法库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
Amlodipine Besylate/Valsartan
Tablet
Refer to USP
07/28/2016
Amoxicillin
Tablet
Refer to FDA's Dissolution Guidance, 2018
07/02/2020
Amoxicillin
For Oral Suspension
II (Paddle)
50
Water (degassed)
900
5, 10, 15, 20, 30 and 45
06/06/2013
Amoxicillin
Capsule
Refer to FDA's Dissolution Guidance, 2018
07/02/2020
Amoxicillin
Tablet (Extended Release)
II (Paddle)
100
3 Stage dissolution: 50 mM potassium phosphate monobasic buffer at pH 4.0 (0-2 hours), 6.0 (2-4 hours) and 6.8 ( 4 hours and beyond)
900
0.25, 0.5, 1, 2, 2.25, 2.5, 3, 4, 4.25, 4.5, 5 and 6 hours
10/21/2010
Amoxicillin/Clarithromycin/Lansoprazole
Capsule/Tablet/Capsule (Copackage)
Refer to USP for monographs of Amoxicillin Capsules, Clarithromycin Tablets and Lansoprazole Delayed-Release Capsules
02/28/2013
Amoxicillin/Clarithromycin/Omeprazole
Capsule/Tablet/Capsule (Copackage)
Refer to USP for monographs of Amoxicillin Capsules, Clarithromycin Tablets and Omeprazole Delayed-Release Capsules
02/28/2013
Amoxicillin/Clavulanate Potassium
Tablet (Chewable)
Refer to USP
01/14/2008
Amoxicillin/Clavulanate Potassium
Tablet
Refer to USP
0, 0.5, 1, 2, 3, 4 and 5 hours
10/04/2012
Amoxicillin/Clavulanate Potassium
Suspension
II (Paddle)
75
Water (deaerated)
900
5, 10, 15 and 30
01/14/2004
Amoxicillin/Omeprazole Mg./Rifabutin
Capsule (Delayed Release)
I (Basket
100
Amoxicillin/Rifabutin: 0.01 N HCl; Omeprazole: 0.1N HCl; Buffer Stage: 0.05M Phosphate buffer, pH 6.8
Amoxicillin/Rifabutin: 5, 10, 15, 20 and 30; Omeprazole: Acid Stage: 120; Buffer Stage: 5, 10, 15, 20 and 30;
08/27/2020
Amphetamine
Tablet (Extended Release, Orally Disintegrating)
II (Paddle
75
Acid Stage: 0.1 N HCl; Buffer Stage: Phosphate Buffer, pH 6.8
Acid Stage: 10, 15, 30, 45, 60, 90, 120; Buffer Stage: 5, 10, 15, 30 and 45
07/28/2016
Amphetamine
Suspension (Extended Release)
Develop a dissolution method
12/22/2016
Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate
Tablet
I (Basket)
100
Deionized Water
500
10, 20, 30 and 45
11/25/2008
Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate
Capsule (Extended Release)
II (Paddle)
50
Dilute HCl, pH 1.1 for first 2 hrs, then add 200 mL of 200 mM Phosphate Buffer and adjust to pH 6.0 for the remainder
0.5, 1, 2, 3, and 4 hours
07/25/2007
Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate [12.5, 25, 37.5, 50 mg]
Capsule (Extended Release)
II (Paddle)
50
Media 1: pH 1.1±0.1, Dilute HCl 2 hours; Media 2: pH 6.0±0.1, Phosphate Buffer 3rd hour, Media 3: pH 7.5±0.1, Phosphate Buffer for the remainder
0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours
11/16/2017
Amphetamine ER
Capsule
II (Paddle)
50
750 ml of dilute HCl, pH 1.1 for the first 2 hours, then add 200 ml of 200 mM phosphate buffer, and adjust to pH 6 (w/ HCl or NaOH) for the remainder
1, 2, 3, 4, and 6 hours
08/17/2006
Amphotericin B
Injectable (Liposomal)
Develop a method to characterize in vitro release
07/28/2016
Ampicillin/Ampicillin Trihydrate
for Oral Suspension
II (Paddle)
25
Water (deaerated)
900
5, 10, 15, 20
01/03/2007
Amprenavir
Capsule
II (Paddle)
50
0.1 N HCl
900
10, 15, 30, and 45
02/19/2008