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
Nebivolol/Valsartan
Tablet
I (Basket)
100
67 mM Phosphate Buffer pH 6.8 with 0.5% SDS
900
5, 10, 15, 20 and 30
10/20/2016
Nebivolol HCl
Tablet
II (Paddle)
50
0.01 N HCl
900
10, 20, 30 and 45
01/15/2010
Nateglinide
Tablet
II (Paddle)
50
0.01 N HCl with 0.5% (w/v) SLS
1000
10, 20, 30 and 45
01/03/2007
Naratriptan HCl
Tablet
Refer to FDA's Dissolution Guidance, 2018
07/02/2020
Naproxen/Esomeprazole Magnesium
Tablet (Delayed Release)
II (Paddle) with sinkers
Naproxen:: Acid Stage: 0.1M HCl; Buffer Stage: 0.05M Phosphate buffer, pH 6.8. Sampling for Acid stage: Transfer the un-dissolved tablet & sinker to the vessel containing the buffer stage medium. Add, 10 mL of 10 M NaOH to each vessel of the remaining acid stage medium. Continue rotation at 100 rpm for 30 minutes, withdraw aliquot and analyze. Esomeprazole (second set of tablets)(without pre-exposure to acid stage):: 0.05M Phosphate buffer, pH 7.4
Naproxen:: Acid stage: 120; Buffer stage: 10, 20, 30, 45, 60, 75 and 90; Esomeprazole::10, 20, 30, 45, 60, 75 and 90
06/06/2013
Naproxen Sodium/Sumatriptan Succinate
Tablet
I (Basket)
75
Phosphate Buffer, pH 6.8
900
10, 15, 20, 30 and 45
07/01/2010
Naproxen Sodium/Diphenhydramine HCl
Tablet
II (Paddle)
75
0.1M Sodium Phosphate Buffer, pH 7.4
900
5, 10, 15, 20, 30 and 45
05/28/2015
Naproxen Sodium/Diphenhydramine HCl
Tablet
II (Paddle)
75
0.1M Sodium Phosphate buffer, pH 7.4 (deaerated)
900
5, 10, 15, 20 and 30
06/25/2015
Naproxen Sodium
Capsule
II (Paddle)
75
Sodium Phosphate Buffer, pH 7.4 ± 0.05
900
10, 15, 20, 30 and 45
05/28/2015
Naproxen Sodium
Tablet
Refer to USP
10/04/2012
Naproxen Sodium
Tablet (Extended Release)
II (Paddle)
50
Phosphate Buffer, pH 7.5
900
0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 14 hours
04/08/2010
Naproxen
Tablet
Refer to USP
07/25/2007
Naproxen
Tablet (Delayed Release)
Refer to USP
12/15/2009
Naproxen
Suspension
Develop a dissolution method
11/16/2017
Naltrexone HCl/Bupropion HCl
Tablet (Extended Release)
II (Paddle)
50
Water (degassed)
900
0.5, 1, 1.5, 2, 3, 4, 6 and 8 hours
09/03/2015
Naltrexone HCl / Oxycodone HCl
Capsule (Extended Release)
Develop a dissolution method
12/22/2016
Naltrexone HCl
Tablet
Refer to FDA's Dissolution Guidance, 2018
07/02/2020
Naltrexone
Injectable Suspension
Phosphate buffered saline with 0.02% Tween 20 and 0.02% Sodium azide, pH 7.4 (final osmolality should be 270 ± 20 mOsm), or any other appropriate medium, at 37°C. Develop an in vitro release method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency
09/01/2011
Naloxegol Oxalate
Tablet
Refer to FDA's Dissolution Guidance, 2018
07/02/2020
Naldemedine
Tablet
Refer to FDA's Dissolution Guidance, 2018
07/02/2020