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
Nilotinib Hydrochloride Monohydrate Capsule I (Basket) 100 0.1 N HCl 1000 10, 15, 30 and 45 2009/10/30
Nilutamide Tablet Develop a dissolution method 2009/05/20
Nimodipine Capsule Develop a dissolution method 2023/09/15
Nintedanib Esylate Capsule II (Paddle) with sinker 100 0.1 N HCl 900 10, 15, 20, 30, 45 and 60 2015/09/03
Niraparib Capsule II (Paddle) with sinker 50 Tier 1: 0.08M Sodium Acetate Buffer, pH 4.0; Tier 2: 0.08M Sodium Acetate Buffer, pH 4.0 containing pepsin (750,000 units/L) 900 10, 15, 20, 30, 45 and 60 2017/11/02
Niraparib Tosylate Tablet II (Paddle) 60 0.1 M Citrate buffer, pH 4.6 900 5, 10, 15, 20, 25, 30 and 45 2024/02/05
Nirmatrelvir (NIR); Ritonavir (RIT) Tablet (copackage) II (Paddle) 75 NIR: 0.05 M Sodium Phosphate, pH 6.8 with 0.2% Sodium Dodecyl Sulfate; RIT: Refer to USP 900 15, 20, 30, 45 and 60 2024/08/05
Nirogacestat Hydrobromide Tablet II (Paddle) 75 pH 1.2 HCl buffer 500 5, 10, 15, 20, 30, 45 and 60 2025/09/08
Nisoldipine Tablet (Extended Release) II (Paddle) with option to use a sinker 50 HCl with SLS (32.5 ± 0.1 g Sodium Lauryl Sulfate in 6489 mL of purified water containing 17.0 mL HCl, pH adjusted to 1.20 ± 0.05 with HCl) 900 1, 4, 8, 12, 15, 18 and 24 hours 2009/04/02
Nitazoxanide Oral Suspension II (Paddle 100 Phosphate buffer at pH 7.5 with 6% hexadecyltrimethyl ammonium bromide, bath temperature at 25ºC 900 10, 20, 30, 45 and 60 2010/10/21
Nitazoxanide Tablet II (Paddle) 75 Phosphate buffer at pH 7.5 with 6% hexadecyltrimethyl ammonium bromide, bath temperature at 25ºC 900 10, 20, 30, 45, 60 2007/01/03
Nitisinone Tablet II (Paddle) 50 Phosphate Buffer, pH 6.8 2 mg tablets: 500 mL; 5 mg and 10 mg tablets: 900 mL 10, 15, 20, 30, 45, 60, 75 and 90 2018/02/15
Nitisinone Capsule II (Paddle) with sinker 50 Phosphate Buffer, pH 6.8 1000 5, 10, 15, 20, 30 and 45 2017/11/02
Nitisinone Suspension II (Paddle) 50 pH 1.2 HCl Buffer (degassed) 1000 10, 15, 20, 30 and 45 2016/12/22
Nitrofurantoin Capsule Refer to USP 2009/04/02
Nitrofurantoin Suspension II (Paddle) 50 Phosphate Buffer, pH 7.2 900 15, 30, 60, 120 and 180 2009/04/02
Nitroglycerin Film, Transdermal (Extended Release) Modified USP Type V (Paddle-over-disk) 100 Deionized Water at 32º C 900 10, 20, 30, 45, 60, 90, 120 and 180 2010/04/08
Nitroglycerin Tablet (Sublingual) II (Paddle) 50 Phosphate Buffer, pH 6.5 500 1, 3, 5, 8, and 10 2010/01/15
Nizatidine Capsule Develop a dissolution method 2024/01/03
Norethindrone Tablet Refer to USP 2009/10/08

数据库说明:

当前数据更新日期:2025年12月20日。
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