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
Nelfinavir Mesylate Powder for Suspension II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20, 30, and 45 2007/09/13
Neomycin Sulfate Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 6.8 900 15, 30, 45 and 60 2008/01/14
Nepafenac Ophthalmic Suspension Develop a method to characterize in vitro release 2014/08/14
Netupitant/Palonosetron HCl Capsule II (Paddle) Netupitant:100; Palonosetron: 75 Netupitant: 0.07M Phosphate buffer pH 6.8 containing 1% sodium SDS ; Palonosetron: 0.01 N HCl Netupitant: 900; Palonosetron: 500 Netupitant: 10, 20, 30, 45, 60 and 75; Palonosetron: 5, 10, 15, 20, 30 and 45 2015/09/03
Nevirapine Tablet (Extended Release) I (Basket) 75 0.04 M Sodium phosphate buffer pH 6.8 containing 2% sodium lauryl sulfate 900 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 20 hours 2013/01/31
Nevirapine Suspension II (Paddle) 25 0.1 N HCl 900 10, 20, 30, 45 and 60 2004/02/11
Nevirapine Tablet Refer to USP 2007/09/13
Niacin Tablet (Extended Release) Develop a dissolution method 2023/09/15
Niacin/Simvastatin Tablet (Extended Release) Simvastain: I (10 mesh rotating Basket) 100 Niacin: Develop a dissolution method; Simvastatin: 0.5 % SDS in 0.01 M Sodium Phosphate, pH 7.0 900 Simvastatin: 10, 20, 30, 45 and 60 2023/09/15
Nicardipine HCl Capsule II (Paddle) 50 0.033 M Citric Acid Buffer, pH 4.5 900 10, 20, 30 and 45 2004/02/11
Nicardipine HCl Capsule (Extended Release) II (Paddle) 50 0.1 N HCl 1000 0.5 , 2 and 6 hours 2008/07/14
Nicotine Film, Transdermal (Extended Release) Develop a dissolution method 2024/01/03
Nicotine Polacrilex Lozenge (Mini) III (Reciprocating Cylinder) 20 dpm Phosphate buffer pH 7.4 250 15, 30, 45, 60 and 90 2017/03/09
Nicotine Polacrilex Lozenge I (Basket) 100 Phosphate Buffer, pH 7.4 900 0.5, 1, 2, 3, 6 and 8 hours 2010/12/23
Nicotine Polacrilex Chewing Gum Chewing Machine as desribed in European Pharmacopoeia (2.9.25) 60 cycles (chews) per minute Phosphate Buffer, pH 7.4 or or any other appropriate buffer and conditions 20 5, 10, 20 and 30 2012/01/05
Nifedipine Capsule Refer to USP 2011/03/03
Nifedipine Tablet (Extended Release) Develop a dissolution method 2024/01/03
Nifurtimox Tablet II (Paddle) 100 Acetate buffer pH 4.5 with 1% sodium dodecyl sulfate (SDS) for 30 mg strength and 1.5 % SDS for 120 mg strength 900 15, 30, 45, 60, 90 and 120 2023/02/09
Nifurtimox Tablet II (Paddle) 100 Acetate Buffer, pH 4.5 with 1.0 % Sodium Dodecyl Sulfate (SDS) (for 30 mg strength) and 1.5 % SDS (for 120 mg strength) 900 10, 20, 30, 60 and 75 2022/07/07
Nilotinib HCl Capsule I (Basket) 100 0.1 N HCl 1000 10, 15, 20, 30 and 45 2024/02/05

数据库说明:

当前数据更新日期:2025年12月20日。
©2006-2025 DrugFuture->FDA-Recommended Dissolution Methods Database