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
Itraconazole Capsule II (Paddle) 100 SGF without Enzyme 900 10, 20, 30, 45, 60 and 90 2004/02/04
Itraconazole Tablet II (Paddle) 75 0.1 N HCl 900 5, 15, 30, 45, 60, 75 and 90 2013/08/15
Ivabradine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Ivacaftor Tablet II (Paddle) with sinker 65 50 mM Sodium Phosphate Buffer with 0.7% Sodium Dodecyl Sulfate (SDS), pH 6.8 900 5, 10, 15, 20 and 30 2015/06/25
Ivacaftor/lumacaftor Tablet Lumacaftor: II (Paddle); Ivacaftor: II (Paddle) Lumacaftor:65; Ivacaftor: 65 Lumacaftor: 0.5% (w/v) CTAB in 50 mM Sodium Acetate Trihydrate buffer (pH 4.5); Ivacaftor: 0.4% (w/v) SLS in 50 mM Sodium Phosphate buffer (pH 6.8) Lumacaftor: 900; Ivacaftor: 900 5, 10, 15, 20 and 30 2016/03/17
Ivacaftor/Tezacaftor [FDC: IVA+ TEZ]; Ivacaftor [IVA] Tablet/Tablet (Copackage) II (Paddle) with option to use a sinker FDC: IVA: 65/TEZ:75; IVA: 65 FDC: IVA: 50 mM Sodium Phosphate Buffer with 0.4% Sodium Dodecyl Sulfate (SDS), pH 6.8/TEZ: 0.2 SDS% in 0.1 N HCl; IVA: 50 mM Sodium Phosphate Buffer with 0.7% SDS, pH 6.8; FDC: IVA: 900/ TEZ: 900; IVA: 900 5, 10, 15, 20, 30 and 45 2019/03/07
Ivermectin Tablet II (Paddle) 50 0.5% SDS in 0.01 M Monobasic Sodium Phosphate, pH 7.0 900 10, 20, 30, 45 and 60 2004/02/04
Ivosidenib Tablet II (Paddle) 50 50 mM Phosphate Buffer pH, 6.8 with 0.6% sodium dodecyl sulfate (SDS), 900 10, 15, 20, 30 and 45 2020/08/27
Ixazomib Citrate Capsule I (Basket) 100 0.1 N HCl 500 5, 10, 15, 20 and 30 2016/10/20
Ketoconazole Tablet I (Basket) 100 Simulated gastric fluid w/o pepsin 800 15, 30, 45, 60 and 90 2007/01/03
Ketoprofen Capsule II (Paddle with sinker) 50 0.05M Potassium Phosphate Buffer, pH 7.4 1000 10, 20, and 30 2023/02/09
Ketoprofen Tablet II (Paddle) 50 SIF Buffer without enzyme, pH 7.4 900 10, 20, 30, 45 and 60 2004/02/05
Ketorolac Tromethamine Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Labetalol HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Lacosamide Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Lacosamide Capsule (Extended Release) I (Basket) 100 Phosphate Buffer, pH 6.8 900 0.5, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours 2024/05/31
Lamivudine Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Lamivudine 150 mg/Zidovudine 300mg Tablets and Abacavir Sulfate 300 mg Tablets-co-packaged Tablet II (Paddle) 75 0.1 N HCl 900 5, 10, 15, 20, 30 and 40 2007/01/03
Lamivudine/Raltegravir Ka Tablet Develop a dissolution method 2023/09/15
Lamivudine/Stavudine/Nevirapine Tablet II (Paddle) 75 0.1 N HCl 900 10, 20, 30, 45 and 60 2007/01/03

数据库说明:

当前数据更新日期:2025年12月17日。
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