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
Lamivudine/Zidovudine Tablet Refer to USP 2017/11/02
Lamivudine/Zidovudine + Efavirenz Tablet (Copackage) II (Paddle) Lamivudine and Zidovudine: 75 Lamivudine and Zidovudine: 0.1 N HCl Efavirenz: Develop a dissolution method Lamivudine and Zidovudine: 1000 10, 20, 30, and 45 2023/09/15
Lamivudine/Zidovudine + Nevirapine Tablet (Copackage) II (Paddle) 50 Lamivudine and Zidovudine: Develop a dissolution method Nevirapine: 0.06 M HCl (pH 1.2) 900 10, 15, 30, 45 and 60 2023/09/15
Lamivudine/Zidovudine/ Nevirapine Tablet II (Paddle) 50 0.01 N HCl 900 10, 15, 30, 45 and 60 2007/01/03
Lamotrigine Tablet (Chewable dispersible) II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 2008/01/14
Lamotrigine Tablet, For Suspension Refer to USP 2023/02/09
Lamotrigine Tablet (Regular) II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 2006/03/04
Lamotrigine Tablet (Extended Release) Refer to USP 2016/02/18
Lansoprazole Capsule (Delayed Release) Refer to USP 2008/11/04
Lansoprazole Tablet (Delayed Release, Orally Disintegrating) II (Paddle) 75 Acid Stage: 0.1 N HCl; Buffer Stage: Phosphate Buffer, pH 6.8 with 5 mM Sodium Dodecyl Sulfate 500 (Acid), 900 (Buffer) 60 (Acid), 10, 20, 30 and 45 (Buffer) 2008/11/04
Lanthanum Carbonate Chewable Tablet Reciprocating Cylinder (Apparatus 3 modified) 10 dpm (dip rate per minute) 0.25 N HCl 900 (modified from the standard apparatus 3 vessel to achieve sink condition) 10, 20, 30 and 45 2007/01/03
Lapatinib Ditosylate Tablet II (Paddle) 55 2% Polysorbate 80 in 0.1 N HCl 900 10, 15, 30 and 45 2009/10/30
Lasmiditan Succinate Tablet Refer to FDA's Dissolution Guidance, 2018 2022/05/12
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

数据库说明:

当前数据更新日期:2025年12月17日。
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