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
Chloroquine Phosphate Tablet Refer to FDA's Dissolution Guidance, 2018 2020/04/16
Chlorothiazide Suspension Develop a dissolution method 2019/03/07
Chlorpheniramine Maleate Tablet (Extended Release) III (Reciprocating Cylinder) 27 dpm Row 1: Test Fluid 1 (0.1N HCl) for 1st hour. Row 2: Test fluid 2 (Phosphate Buffer, pH 7.5) for 5th hour Row 1: 250 mL. Row 2: 250 mL 1 hour for test fluid 1, and 4 hours for test fluid 2 2007/07/25
Chlorpheniramine Maleate/Codeine Phosphate Tablet (Extended Release) II (Paddle) 50 Simulated gastric fluid (SGF) without enzyme (pH 1.2) 900 0.5, 1, 2, 4, 6, 8 and 12 hours 2016/10/20
Chlorpheniramine Maleate/Ibuprofen/Phenylephrine HCl Tablet II (Paddle) 50 50 mM Potassium Phosphate Buffer, pH 6.5 (degassed) 900 5, 10, 15, 20 and 30 2015/06/25
Chlorpheniramine Maleate/Ibuprofen/Pseudoephedrine HCl Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 6.5 900 10, 20, 30 and 45 2004/02/20
Chlorpheniramine Polistirex/ Codeine polistirex Suspension (Extended Release) II (Paddle) 50 Acid Stage: 0.1 N HCl; Buffer Stage: pH 6.8 Phosphate Buffer [500 mL 0.1 N HCl for 1 hour, followed by addition of 400 mL of 0.2M NaH2P04 to pH 6.8] Acid Stage: 500 mL; Buffer Stage: 900 mL Acid Stage: 1 hour; Buffer Stage: 1, 2, 4, 6, 8 and 12 hours 2016/03/17
Chlorpheniramine Polistirex/Hydrocodone Polistirex Extended Release Oral Suspension II (Paddle) 50 Simulated Gastric Fluid (SGF) at 37ºC ± 0.5ºC 495 1, 2, 3, 6, 8, 12, 16 and 24 hours 2011/06/30
Chlorpheniramine Polistirex/Hydrocodone Polistirex Capsule (Extended Release) II (Paddle) 50 Simulated Intestinal Fluid without enzyme 500 1, 4, 12, and 24 hours 2008/11/25
Chlorpromazine HCl Tablet Refer to USP 2012/01/05
Chlorthalidone Tablet Develop a dissolution method 2024/01/03
Chlorzoxazone Tablet Develop a dissolution method 2024/01/03
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

数据库说明:

当前数据更新日期:2026年02月10日。
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