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
Ceftibuten Dihydrate Suspension II (Paddle) 50 0.05 M Phosphate Buffer, pH 7.0 1000 10, 20, 30 and 45 2004/01/21
Cefuroxime Axetil Tablet Refer to USP 2007/07/25
Celecoxib Capsule II (Paddle) 50 mg, 100 mg and 200 mg: 50 rpm; 400 mg: 75 rpm Tier 1 Medium: 0.04 M tribasic sodium phosphate (pH 12) with 1% SLS. Tier 2 Initial Medium: 750 mL of simulated gastric fluid, USP (includes pepsin); At 20 minutes, while stirring, add 180 mL of appropriate concentrations of SLS solution (for a final concentration of 1% SLS). Add about 70 mL of 1.2 N NaOH to adjust the pH to 12. Tier 1: 1000 mL Tier 2: 750 mL (initial) 1000 mL (final) 10, 20, 30, 45 and 60 2010/07/01
Celecoxib; Tramadol HCl Tablet II (Paddle) 75 0.1N Hydrochloric Acid + 2% SLS 1000 5, 10, 15, 20, 30, 45 and 60 2023/07/07
Cenobamate Tablet Refer to FDA's Dissolution Guidance, 2018 2024/08/05
Cephalexin Suspension Develop a dissolution method 2023/09/15
Cephalexin Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Ceritinib Capsule II (Paddle) 60 0.01 N HCl (degassed) 900 5, 10, 15, 20 and 30 2015/08/27
Ceritinib Tablet I (Basket) 75 0.01 N HCl (degassed) 900 5, 10, 15, 20 and 30 2021/04/22
Cetirizine Capsule (Soft-Gelatin) II (Paddle) 50 25 mM pH 6.8 phosphate buffer 900 5, 10, 15, 20, 30 and 45 2015/01/15
Cetirizine HCl Tablet (Regular & Chewable) Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Cetirizine HCl Tablet (Orally Disintegrating) Refer to USP 2016/03/17
Cetirizine HCl/Pseudoephedrine HCl Tablet (Extended Release) I (Basket) 100 0.1 N HCl 500 0.17, 0.25, 0.5, 1, 2, 6 and 8 hours 2007/06/18
Cevimeline HCL Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Chlorambucil Tablet II (Paddle) 75 0.1 N HCl 900 10, 20, 30, and 45 2006/08/17
Chlordiazepoxide HCl/ Clidinium Bromide Capsule Develop a dissolution method 2024/01/03
Chlorhexidine Gluconate Tablet (Dental) Develop a method to characterize in vitro release 2022/07/07
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

数据库说明:

当前数据更新日期:2025年12月08日。
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