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
Cefixime Tablet (Chewable) II (Paddle 25 Phosphate Buffer, pH 7.2 900 10, 15, 20, 30, and 45 2010/12/23
Cefixime Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Cefixime Capsule I (Basket) 100 0.05 M Phosphate Buffer, pH 7.2 900 10, 20, 30, 45 and 60 2013/08/15
Cefixime Suspension II (Paddle) 50 0.05 M Phosphate buffer, pH 7.2 900 10, 20, 30 and 45 2007/04/09
Cefpodoxime Proxetil Tablet Refer to USP 2007/07/25
Cefpodoxime Proxetil Suspension II (Paddle) 50 Glycine Buffer (0.04 M) pH 3.0 900 10, 20, 30 and 45 2005/12/20
Cefprozil Tablet Develop a dissolution method 2024/01/03
Cefprozil For Oral Suspension Develop a dissolution method 2023/09/15
Cefprozil Monohydrate Suspension Develop a dissolution method 2023/09/15
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
Celocoxib Suspension II (Paddle) 75 40 mM Sodium Phosphate Tribasic Buffer, pH 11.1 with 0.5% SDS 1000 5, 10, 15, 20, 30, 45 and 60 2026/03/25
Cenobamate Tablet Refer to FDA's Dissolution Guidance, 2018 2024/08/05
Cephalexin Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Cephalexin Tablet Refer to FDA's Dissolution Guidance, 2018 2026/03/25
Cephalexin Suspension Develop a dissolution method 2023/09/15
Ceritinib Tablet I (Basket) 75 0.01 N HCl (degassed) 900 5, 10, 15, 20 and 30 2021/04/22
Ceritinib Capsule II (Paddle) 60 0.01 N HCl (degassed) 900 5, 10, 15, 20 and 30 2015/08/27

数据库说明:

当前数据更新日期:2026年04月19日。
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