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
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 Refer to FDA's Dissolution Guidance, 2018 2020/07/02
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 (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
Levonorgestrel Intrauterine Device Develop a method to characterize in vitro release 2014/02/14
Levorphanol Tartrate Tablet Refer to FDA's Dissolution Guidance, 2018 2021/04/22
Levothyroxine Sodium Capsule I (Basket) 100 0.01 N HCl, pH 2.05 500 5, 10, 15, 20, 30, 45 and 60 2026/05/22
Levothyroxine Sodium Tablet Refer to USP 2007/07/25
Lidocaine Patch Paddle over Disk (Apparatus 5) 50 Acetic acid/sodium acetate buffer, pH 4.0 at 32ºC 500 10, 20, 30, 60, 120 and 180 2007/01/03
Lidocaine System VI (Cylinder) 50 Diluted McIlvaine buffer solution, pH 5.5 900 60, 120, 180, 360 and 1440 2026/05/22
Linaclotide Capsule I (Basket) 50 50 mM Phosphate Buffer, pH 4.5 500 5, 10, 15, 20 and 30 2015/12/24
Linagliptin Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02

数据库说明:

当前数据更新日期:2026年06月15日。
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