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
Cabotegravir (CABO); Rilpivirine (RILP) Suspension, Extended release II (Paddle) 20 (CABO); 50 (RILP) 0.5% w/v solution of cetyltrimethylammonium bromide (CTAB) in 140 mM McIlvaine buffer, pH 7.4 (CABO); 6.0% w/v Polysorbate 20 in 0.05 M Sodium Phosphate buffer, pH 7.4 (RILP) 5, 10, 15, 20, 30, 45 and 60 (CABO); 5, 30, 90 and 360 (RILP) 2023/05/18
Cabotegravir Sodium Tablet II (Paddle) 60 0.01N HCl with 0.2% cetyltrimethylammonium bromide (CTAB) 1000 5, 10, 15, 20, 25 and 30 2022/07/07
Cabozantinib S-Malate Capsule II (Paddle) with sinker 75 0.01 N HCl with 0.5% Triton X-100 (degassed) 900 5, 10, 15, 20 and 30 2016/06/02
Cabozantinib S-Malate Tablet II (Paddle 75 0.01 N HCl with 0.375% Triton X-100 (degassed) 900 5, 10, 15, 20 and 30 2016/07/28
Caffeine; Ergotamine Tartrate Suppository II (Paddle) 50 1% Tartaric Acid 900 10, 15, 30, 35, 40 and 45 2024/02/05
Calcifediol Capsule (Extended Release) II (Paddle) with sinker 75 0.5% SDS in 5 mM Sodium Dihydrogenphosphate Monohydrate, pH 6.8 500 1, 2, 4, 6, 8, 10 and 12 hours 2016/10/20
Calcitriol Capsule Develop a quantitative rupture test 2008/06/03
Calcium Acetate Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Calcium Acetate Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Calcium carbonate/Famotidine/ Magnesium hydroxide Tablet, Chewable III (Reciprocating Cylinder) 0.1 M Sodium Acetate, pH 4.5 900 5,10, 15, 20, 30 and 45 2023/03/30
Canagliflozin Tablet Develop a dissolution method 2023/09/15
Canagliflozin (Can)/ Metformin HCl (Met) Tablet (Extended Release) Met: I (Basket, 40 mesh): Can: I (Basket, 10 mesh [with option of tablet holder]) Met: 100: Can:100 Met: Simulated Gastric Fluid [SGF] without enzyme, pH 1.2; Can: 0.1% (w/v) polysorbate 20 in 0.05 M sodium phosphate buffer pH 6.8 ( 50 mg); 0.2% (w/v) polysorbate 20 in 0.05 M sodium phosphate buffer pH 6.8 (150 mg) Met: 900: Can: 900 Met: 1, 2, 4, 6, 8 10 and 12 hours: Can: 10, 15, 20, 30, 45 and 60 minutes; 2016/12/22
Canagliflozin/Metformin HCl Tablet II (Paddle) Canagliflozin: 75; Metformin: 50 Canagliflozin (50 mg): 0.025 % Polysorbate 20; Canagliflozin (150 mg):0.075 % Polysorbate 20; Metformin: Phosphate buffer, pH 6.8 Canagliflozin (50 mg): 900; Canagliflozin (150 mg): 900 ; Metformin: 1000 Canagliflozin: 10, 15, 20, 30 and 45; Metformin: 5, 10, 15, 20 and 30 2015/05/28
Candesartan Cilexetil (16 mg, 8 mg and 4 mg) Tablet II (Paddle) 50 0.35% Polysorbate 20 in 0.05 M Phosphate Buffer, pH 6.5 900 10, 20, 30, 45 and 60 2007/06/20
Candesartan Cilexetil (32 mg) Tablet II (Paddle) 50 0.70% Polysorbate 20 in 0.05 M Phosphate Buffer, pH 6.5 900 10, 20, 30, 45 and 60 2007/06/20
Candesartan Cilexetil/Hydrochlorothiazide (16/12.5 mg) Tablet II (Paddle) 50 0.35% Polysorbate 20 in phosphate buffer pH 6.5 900 10, 20, 30, 45 and 60 2010/01/29
Candesartan Cilexetil/Hydrochlorothiazide (32/12.5 mg and 32/25 mg) Tablet II (Paddle) 50 0.70% Polysorbate 20 in phosphate buffer pH 6.5 900 15, 20, 30, 45 and 60 2010/01/29
Capecitabine Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Capivasertib Tablet II (Paddle) 60 Simulated Gastric Fluid without enzyme, pH 1.2 900 10, 15, 20, 30 and 45 2025/02/24
Capmatinib HCl Tablet I (Basket) 75 0.01N HCl (degassed) 900 5, 10, 15, 20, 30 and 45 2022/05/12

数据库说明:

当前数据更新日期:2025年12月10日。
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