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
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
Captopril Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Carbamazepine Capsule (Extended Release) II (Paddle) 75 First 4 hours: Dilute Acid, pH 1.1. After 4 hours: Phosphate Buffer, pH 7.5 with 0.1% sodium lauryl sulfate (SLS). First 4 h: 900. After 4 h: 900 1, 2, 4, 6, 8, 10 and 12 hours 2011/09/01
Carbamazepine Tablet Develop a dissolution method 2024/01/03
Carbamazepine Tablet (Chewable) Develop a dissolution method 2023/09/15
Carbamazepine Suspension Develop a dissolution method 2023/09/15
Carbamazepine Tablet (Extended Release) Develop a dissolution method 2024/01/03
Carbidopa Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Carbidopa/Entacapone/Levodopa Tablet I (Basket) Carbidopa and Levodopa: 50; Entacapone: 125 For both Carbidopa and Levodopa: 0.1 N HCl, For Entacapone: Phosphate buffer pH 5.5 Carbidopa and Levodopa: 750 ml. Entacapone: 900 ml 10, 20, 30, 45 and 60 2007/01/03
Carbidopa/Levodopa Tablet (Orally Disintegrating) II (Paddle) 50 0.1 N HCl 750 5, 10, 15, 30, and 45 2007/07/25
Carbidopa/Levodopa Suspension (Enteral) II (Paddle) 25 0.05 M Sodium Acetate Buffer, pH 4.5 500 5, 10, 15, 20, 30, 40 and 60 2016/10/20
Carbidopa/Levodopa Tablet (Extended Release) II (Paddle) 50 0.1 N HCl 900 0.5, 0.75, 1, 1.5, 2, 2.5, 3 and 4 hours 2013/08/15

数据库说明:

当前数据更新日期:2026年04月19日。
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