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
Pitavastatin Calcium Tablet I (Basket) 35 0.05 M Phosphate Buffer, pH 6.8 900 5, 10, 15, 20, 30 and 45 2010/12/23
Pomalidomide Capsule II (Paddle) 50 0.1 N HCl 900 10, 15, 20, 30 and 45 2015/05/28
Ponatinib HCl Tablet I (Basket) 50 pH 2.1, KCl/HCl buffer (degassed) 900 10, 15, 20, 30, 45 and 60 2015/09/03
Posaconazole For Suspension (Delayed Release) II (Paddle) 75 Acid stage: 0.01 N HCl; Buffer stage: pH 6.8 Phosphate buffer with 1.3% Tween 80; Acid stage: 750 mL; Buffer stage: 1000 mL Acid stage: 120; Buffer stage: 5, 10, 15, 20, 30 and 45 2022/07/07
Posaconazole Tablet (Delayed Release) II (Paddle) 75 Acid Stage: 0.01 N HCl: Buffer Stage: 50 mM phosphate buffer, pH 6.8 with 0.37 % Polysorbate 80 (after 120 minutes, to the acid stage, add 250 mL of 0.2M Phosphate Buffer, 1.46% Polysorbate 80) Acid Stage: 750 mL; Buffer Stage 1000 mL Acid Stage: 120; Buffer Stage: 10, 15, 20, 30 and 45 2015/06/25
Posaconazole Oral Suspension II (Paddle) 25 0.3% SLS 900 10, 20, 30 and 45 2007/12/03
Potassium Chloride Tablet (Extended Release) Develop a dissolution method 2024/01/03
Potassium Chloride Capsule (Extended Release) Develop a dissolution method 2024/01/03
Potassium chloride For suspension, Extended Release Develop a dissolution method 2026/01/28
Potassium Citrate Tablet Develop a dissolution method 2024/01/03
Pralsetinib Capsule II (Paddle) with sinker 50 50 mM Sodium Phosphate Buffer, pH 6.8, with 0.4% w/v Cetyl Trimethylammonium Bromide (CTAB) 900 10, 20, 30, 45 and 60 2022/07/07
Pramipexole Dihydrochloride Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Pramipexole Dihydrochloride Tablet (Extended Release) I (Basket) 100 0.05 M phosphate buffer, pH 6.8 500 1, 2, 4, 6, 9, 12, 16, 20 and 24 hours 2010/09/02
Prasugrel HCl Tablet II (Paddle) 75 Citrate-Phosphate buffer (0.023M Citric acid+0.026M Sodium Phosphate, Dibasic), pH 4.0 900 10, 15, 20, 30 and 45 2012/10/04
Pravastatin Sodium Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Praziquantel Tablet Refer to USP 2015/06/25
Prazosin HCl Capsule Refer to USP 2022/05/12
Prednisolone Tablet Develop a dissolution method 2024/01/03
Prednisolone Acetate Ophthalmic Suspension Develop an in vitro release method 2014/05/15
Prednisolone Sodium Phosphate Tablet (Orally Disintegrating) II (Paddle) 50 22 mM Sodium Acetate Buffer, pH 4.5 500 5, 15, 30, 45 and 60 2008/09/03

数据库说明:

当前数据更新日期:2026年02月09日。
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