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
Lazertinib Mesylate Tablet II (Paddle) 75 1.0% Polysorbate 20 in 0.1 M Sodium Citrate Buffer (80 mg strength), pH 4.5; 2.0% Polysorbate 20 in 0.1 M Sodium Citrate Buffer, pH 4.5 (240 mg strength) 900 5, 10, 15, 20, 30, 45 and 60 2026/01/28
Ledipasvir/Sofosbuvir Tablet II (Paddle) 75 1.5% Polysorbate 80 in 10 mM Potassium Phosphate Buffer with 0.0075 mg/mL Butylated Hydroxytoluene (BHT), pH 6.0 900 5, 10, 15, 20, 30, 45 and 60 2015/08/27
Ledipasvir/Sofosbuvir Pellets II (Paddle) 75 1.0% polysorbate 80 in 25 mM Potassium Phosphate Buffer, with 0.005 mg/mL Butylated Hydroxytoluene (BHT), pH 5.5 900 5, 10, 15, 20, 30, 45 and 60 2021/08/19
Lefamulin Acetate Tablet II (Paddle) 50 0.1 N HCl 1000 10, 20, 30, 45, 60, 75, and 90 2021/04/22
Leflunomide Tablet Develop a dissolution method 2023/09/15
Leflunomide (100 mg) Tablet Develop a dissolution method 2023/09/15
Lemborexant Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 2022/05/12
Lenacapavir Sodium Tablet II (Paddle) with sinkers 75 30 mM potassium phosphate, pH 6.0 with 2.0% Cremophor EL 900 10, 15, 20, 25, 30, 45 and 60 2024/02/05
Lenalidomide Capsule II (Paddle) 50 0.01 N HCl 900 10, 15, 20, 30 and 45 2008/04/15
Leniolisib Phosphate Tablet I (Basket) 100 Acetate Buffer, pH 4.0 900 10, 20, 30, 40, 50, 60, 70 and 80 2024/08/05
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
Letermovir Pellets II (Paddle) 75 25 mM sodium acetate buffer, pH 4.5 with 0.6% Tween-80 900 5, 10, 15, 20, 30, 45 and 60 2026/03/25
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

数据库说明:

当前数据更新日期:2026年06月14日。
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