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
Cholic Acid Capsule II (Paddle) with sinker 100 Phosphate Buffer, pH 6.8 500 mL for 50 mg capsule; 900 mL for 250 mg capsule 5, 10, 15, 20 and 30 2016/03/17
Choline Fenofibrate Capsule (Delayed Release) II (Paddle) 50 Acid Stage: 0.05M Sodium Phosphate, pH 3.5 ± 0.05; Buffer Stage: 0.05 M Sodium Phosphate, pH 6.8 ± 0.05 Acid stage: 500; Buffer stage: 900 Acid stage: 120; Buffer stage: 15, 30, 60, 90, 120, 240 and 360 2010/07/01
Ciclopirox Topical Suspension Develop a method to characterize in vitro release 2010/03/25
Cilostazol Tablet Develop a dissolution method 2023/09/15
Cimetidine Tablet Refer to USP 2023/11/30
Cinacalcet HCl Tablet II (Paddle) 75 0.05 N HCl 900 10, 20, 30 and 45 2006/01/26
Ciprofloxacin Injectable Suspension [Otic] IV (Flow through cell-closed loop) / 22 mm Flow @ 6 mL/min 50 mM Acetate Buffer, pH 4.5 @37°C ± 0.5 [use glass beads; sample volume: 100 μl] 480 5, 10, 15, 20, 30, 45, 60 and 75 2016/03/17
Ciprofloxacin Oral Suspension II (Paddle) 100 0.05 M Acetate Buffer with 0.025% Brij35 (polyoxyethylene lauryl ether), pH 4.5 900 10, 20, 30 and 45 2010/03/25
Ciprofloxacin HCl Tablet Refer to USP 2010/09/02
Ciprofloxacin HCl Tablet (Extended Release) I (Basket) 100 0.1 N HCl 900 1, 2, 4, and 7 hours or until at least 80% released 2008/01/14
Ciprofloxacin HCl/Hydrocortisone Otic Suspension Develop a method to characterize in vitro release 2011/09/01
Ciprofloxacin/Ciprofloxacin HCl (AB) Tablet (Extended Release) II (Paddle) 50 0.1 N HCl 900 15, 30, 60, and 120 2008/01/14
Ciprofloxacin/Dexamethasone Otic Suspension Develop a method to characterize in vitro release 2016/03/17
Citalopram Capsule Refer to FDA's Dissolution Guidance, 2018 2023/07/07
Citalopram HBr Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Citalopram Hydrobromide Capsule II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 2008/10/06
Cladribine Tablet II (Paddle) 50 Phosphate Buffer, pH 6.8  (deaerated) 900 5, 10, 15, 20 and 30 2022/05/12
Clarithromycin Suspension II (Paddle) 50 0.05 M Phosphate Buffer, pH 6.8 900 10, 20, 30, 45 and 60 2004/01/23
Clarithromycin Tablet (Extended Release) Refer to USP 2008/10/06
Clarithromycin Tablet Refer to USP 2007/07/25

数据库说明:

当前数据更新日期:2026年04月19日。
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