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
Clonidine ( 0.1 mg) Tablet (Extended Release) II (Paddle) with sinker 50 Acid stage: 0.01 N HCl; Buffer stage: Phosphate Buffer, pH 7.0 Acid stage: 500; Buffer stage: 500 Acid stage: 1 and 2 hours; Buffer stage: 1, 2, 4, 6, 10, 14 and 16 hours 2012/01/26
Clonidine ( EQ. 0.17 mg and EQ. 0.26 mg) Tablet (Extended Release) II (Paddle) 50 500 mL 0.1N HCl for the 1st hour, then add 400 mL 0.27M Sodium Phosphate (Dibasic) buffer solution Acid stage: 500; Buffer stage: 900 1, 2, 3, 6, 9, 12, 16, 20 and 24 hours 2010/07/01
Clonidine HCl Tablet Refer to USP 2007/06/18
Clonidine HCl (0.1 mg & 0.2 mg) Tablet (Extended Release) II (Paddle) with sinker 50 Acid stage: 0.01 N HCl; Buffer stage: Phosphate Buffer, pH 7.0 Acid stage: 500; Buffer stage: 500 Acid stage: 1 and 2 hours; Buffer stage: 1, 2, 4, 6, 10, 14 and 16 hours 2015/08/27
Clonidine Hydrochloride Suspension, Extended Release II (Paddle) 50 0.6 M KH2PO4 solution, pH 4.3 900 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 16, 18 and 24 hours 2025/06/23
Clopidogrel Bisulfate Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Clorazepate Dipotassium Tablet Refer to USP 2013/01/31
Clotrimazole Lozenge Refer to USP 2008/10/06
Clotrimazole Tablet (Vaginal) II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 2004/01/24
Clozapine Tablet (Orally Disintegrating) II (Paddle 50 RPM (12.5 mg, 25 mg and 100 mg); 75 RPM (150 mg and 200 mg) pH 4.5 Acetate Buffer 900 5, 10, 15, 20, and 30 2011/06/09
Clozapine Tablet Refer to USP 2011/07/21
Clozapine Suspension II (Paddle) 50 Acetate Buffer (pH 4.0) 900 5, 10, 15, 20 and 30 2015/05/28
Cobicistat Tablet II (Paddle) 75 50 mM Sodium Acetate Buffer, pH 4.5 900 5, 10, 15, 20 and 30 2015/08/27
Cobicistat (Cobi)/ Darunavir Ethanolate (Drv) Tablet Cobi: II (Paddle): Drv: II (Paddle) Cobi: 75; Drv:75 Cobi: 0.05 M Citrate Phosphate Buffer, pH 4.2; Drv: 0.05 M Sodium Phosphate Buffer, pH 3.0, 2% Tween 20 Cobi: 900 mL; Drv: 900 mL Cobi: 5, 10, 15, 20 and 30; Drv: 10, 15, 20, 30 and 45 2016/10/20
Cobicistat/Elvitegravir/ Emtricitabine/Tenofovir Alafenamide Fumarate Tablet II (Paddle) 100 0.05 M sodium citrate buffer pH 5.5 containing 2.0% w/v polysorbate 80 1000 5, 10, 15, 20 and 30 2016/10/20
Cobicistat/Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate Tablet II (Paddle) with sinker 100 0.01 N HCl with 2% w/w Polysorbate 80 1000 5, 10, 15, 20 and 30 2015/06/25
Cobimetinib Fumarate Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Codeine Sulfate Tablet Refer to USP 2011/09/01
Colchicine Capsule Develop a dissolution method 2023/09/15
Colchicine Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02

数据库说明:

当前数据更新日期:2025年12月10日。
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