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
Anagrelide HCl Capsule I (Basket) 100 0.1 N HCl 900 5, 10, 15, 30 and 45 2004/01/14
Anastrozole Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Apalutamide Tablet II (Paddle) 75 0.25% sodium lauryl sulfate (SLS) in 0.05 M Sodium Phosphate Buffer, pH 4.5 (60 mg strength); 0.5% sodium lauryl sulfate (SLS) in 0.05 M Sodium Phosphate Buffer, pH 4.5 (240 mg strength) 900 5, 10, 15, 20, 30, and 45 2024/02/16
Apixaban For Suspension II (Paddle) 50 0.05 M Phosphate Buffer, pH 6.8 500 5, 10, 15, 20, 30, 45 and 60 2026/03/25
Apixaban Tablet II (Paddle) 75 0.05 M Sodium Phosphate Buffer with 0.05% SLS, pH 6.8 900 5, 10, 20, 30 and 45 2013/05/09
Apomorphine HCl Film (Sublingual) V (paddle over disk) 75 20mM BIS-TRIS HCl Buffer, pH 6.4 500 2.5, 5, 7.5, 10, 12.5, 15 and 20 2021/08/19
Apremilast Tablet II (Paddle) 60 0.15% SLS in 25 mM Sodium Phosphate Buffer, pH 6.8 900 10, 15, 20, 30, and 45 2017/05/18
Apremilast Tablet (Extended Release) II (Paddle) with Sinker 75 0.5% Tween 80 in Sodium Acetate Buffer, pH 5.5 900 120, 360, 480, 600, 840, 960, 1080 and 1440 2026/05/22
Aprepitant Emulsion Develop a method to characterize in vitro release 2024/02/05
Aprepitant Capsule Develop a dissolution method 2023/09/15
Aprepitant For Oral Suspension Develop a dissolution method 2023/09/15
Aprocitentan Tablet II (Paddle) 50 Phosphate Buffer, pH 6.8 w/0.05% CTAB and 0.5% Tween 20 900 10, 15, 20, 30 and 45 2025/02/24
Arimoclomol Citrate Capsule II (Paddle) with sinker 75 NaCl/HCl media, pH 1.2 (simulated gastric fluid without enzymes) 1000 5, 10, 15, 20, 30, 45 and 60 2026/01/28
Aripiprazole Suspension (Extended Release) IV (Flow through Cell) with closed system 4 mL/min Acetate buffer, pH 5.0 1000 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 14, 16 and 18 hours 2024/11/01
Aripiprazole Tablet Refer to USP 2016/06/30
Aripiprazole Tablet (Orally Disintegrating) II (Paddle) 75 Acetate Buffer, pH 4.0 1000 10, 20, 30 and 45 2008/08/11
Aripiprazole For Intramuscular Suspension (Extended Release) II (Paddle) 50 0.25% Sodium Dodecyl Sulfate (SDS) Solution 900 10, 15, 30, 60, 120, 180, 240, 300, 360, 420 and 480 2015/06/25
Armodafinil Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 2008/01/14
Asciminib HCl Tablet II (Paddle) 60 Citrate Buffer, pH 3.0 900 5, 10, 15, 20 and 45 2023/10/06
Asenapine Transdermal VI (Cylinder) 50 pH 5.1 Acetate Buffer at 32°C 900 1, 2, 3, 4, 6, 8, 10 and 12 hours 2021/04/22

数据库说明:

当前数据更新日期:2026年06月07日。
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