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
Abacavir Sulfate Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Abacavir Sulfate/Dolutegravir Sodium/Lamivudine Tablet II (Paddle) 85 0.01 M Phosphate Buffer with 0.5% sodium dodecyl sulfate (SDS), pH 6.8 900 Abacavir and lamivudine: 10, 15, 20, 30 and 45; Dolutegravir: 5,15, 25, 35 and 45. 2015/05/28
Abacavir Sulfate/Dolutegravir Sodium/Lamivudine Tablet (For Suspension) II (Paddle) 50 0.01 M Phosphate Buffer with 0.5 mM EDTA, pH 6.8 500 5, 10, 15, 30, 45 and 60 2023/10/06
Abacavir Sulfate/Lamivudine Tablet II (Paddle) 75 0.1 N HCl 900 10, 20, 30, and 45 2007/01/03
Abacavir Sulfate/Lamivudine/Zidovudine Tablet II (Paddle) 75 0.1 N HCl Acid Stage: 900 mL; Buffer Stage: 1000 mL 5, 10, 15, 30 and 45 2007/01/03
Abemaciclib Tablet II (Paddle) 75 0.01 N HCl 900 5, 10, 15, 20 and 30 2017/11/16
Abiraterone Acetate Tablet II (Paddle) 50 0.25% SLS in 56.5 mM phosphate buffer, pH 4.5 900 10, 20, 30, 45 and 60 2013/02/28
Abrocitinib Tablet II (Paddle) with peak vessels 55 Citrate-phosphate buffer, pH 3.5 900 10, 20, 30 and 45 2023/05/18
Acalabrutinib Capsule II (Paddle) 50 0.1 N HCl 900 10, 15, 20 and 30 2023/08/17
Acamprosate Calcium Tablet (Delayed Release) I (Basket) 180 Acid Stage: 0.1 N HCl Buffer Stage: "Citrate-sodium hydroxide" buffer pH 6.8 (150 ml of 2N NaOH, 21.014 gm of citric acid and ultra-pure water to 1000 ml) (Method B) Media 1: 750 mL pH 1.1±0.1; Media 2: 950 mL pH 6.0±0.1; Media 3: 1000 mL pH 7.5±0.1 120 (Acid) 30, 60, 90, 120, and 180 (buffer) 2005/12/20
Acarbose Tablet Develop a dissolution method 2023/09/15
Acarbose Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Acetaminophen Tablet (Extended Release) Refer to USP 2011/03/03
Acetaminophen Suppository II (Paddle) 50 Phosphate buffer, pH 5 900 15, 30, 45, 60 and 90 2006/08/17
Acetaminophen/Aspirin/Caffeine Tablet Refer to USP 2015/06/25
Acetaminophen/Butalbital Tablet Develop a dissolution method 2023/09/15
Acetaminophen/Butalbital/Caffeine Tablet Refer to USP 2008/01/14
Acetaminophen/Butalbital/Caffeine/Codeine Phosphate Capsule Develop a dissolution method 2023/09/15
Acetaminophen/Caffeine/Dihydrocodeine Bitartrate Capsule Develop a dissolution method 2023/09/15
Acetaminophen/Caffeine/Dihydrocodeine Bitartrate Tablet Develop a dissolution method 2023/09/15

数据库说明:

当前数据更新日期:2023年12月03日。
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