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
Lenvatinib Mesylate Capsule II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 2016/03/17
Lesinurad Tablet II (Paddle) 75 pH 4.5 sodium acetate buffer with 1% SLS 900 10, 20, 30 and 45 2016/03/17
Letermovir Tablet II (Paddle) 75 25 mM Na Acetate Buffer, pH 4.5 with 0.6% Tween-80 900 10, 15, 20, 30, 45 and 60 2018/02/08
Letrozole Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Letrozole (LET); Ribociclib Succinate (RIB) Tablet/Tablet (Copackage) II (Paddle) RIB: 50; LET: 75 RIB: 0.01 N HCl; LET: 0.1 N HCl RIB: 900; LET: 900 5, 10, 15, 20, 30 and 45 2019/03/07
Leucovorin Calcium Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Leuprolide Acetate Implant Develop a method to characterize in vitro releas 2022/05/12
Leuprolide Acetate Injectable (Extended Release) Develop a dissolution method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency 2010/01/15
Leuprolide Mesylate Emulsion Develop a method to characterize in vitro release 2023/10/06
Levacetylleucine For Suspension II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 30 and 45 2026/01/28
Levetiracetam Tablet, for Suspension II (Paddle) 50 Phosphate Buffer, pH 6.8 (degas) 900 2.5, 5, 10, 15 and 20 2017/03/02
Levetiracetam Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Levetiracetam (1 g and 1.5 g) Tablet (Extended Release) III (Reciprocating Cylinder) 15 dips/min Sodium acetate buffer, pH 4.5 900 1, 2, 4, 6, 8, 10 and 12 hours 2024/11/01
Levetiracetam (500 mg and 750 mg) Tablet (Extended Release) I (Basket) 100 0.05 M Phosphate Buffer, pH 6.0 900 1, 2, 4, 6, 8 and 12 hours 2009/04/02
Levocarnitine Tablet Develop a dissolution method 2024/01/03
Levocetirizine Dihydrochloride Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Levofloxacin Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Levoketoconazole Tablet II (Paddle) 50 0.05 N HCl 900 10, 20, 30, 45 and 60 2025/06/23
Levomilnacipran HCl Capsule (Extended Release) Develop a dissolution method 2023/09/15
Levonorgestrel Tablet II (Paddle) 75 0.1 N HCl with 0.1% SLS 1000 10, 20, 30, 45, 60 and 90 2004/02/05

数据库说明:

当前数据更新日期:2026年02月07日。
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