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
Paliperidone Tablet (Extended Release) II (Paddle) 50 Modified SGF, pH 1.0 [NaCl (0.2% w/w) in 0.0825N HCl] 500 1, 2, 4, 6, 8, 12, 14, 18 and 24 hours 2009/08/27
Paliperidone Palmitate Intramuscular Suspension (Extended Release) II (Paddle) 50 0.489% (w/v) Polysorbate 20 in 0.001 N HCl @25.0 °C. 900 1.5, 5, 8, 10, 15, 20, 30 and 45 2011/09/01
Paliperidone Palmitate [3-month injection] Intramuscular Suspension (Extended Release) II (Paddle) 50 0.489% (w/v) Polysorbate 20 in 0.001 N HCl @25.0 °C. 900 5, 30, 60, 90, 120, 180, 240, 300 and 360 2016/03/17
Palonosetron HCl Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Palovarotene Capsule II (Paddle) with sinkers 50 5 mM Phosphate buffer, pH 8.0 with 0.5% SLS 900 5, 10, 15, 30, 45 and 60 2024/11/01
Pancrelipase Capsule (Delayed Release) Refer to USP 2016/03/17
Pancrelipase Tablet II (Paddle) 50 Phosphate Buffer, pH 4.5 900 10, 20, 30, 45 and 60 2016/06/02
Panobinostat Lactate Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Pantoprazole Sodium Tablet (Delayed Release) Refer to USP 2009/07/21
Pantoprazole Sodium Delayed Release Granules for Oral Suspension II (Paddle) 100 Acid Stage: 0.1 N Hydrochloric Acid; Buffer Stage: 0.05 M Tribasic Sodium Phosphate (Add 250 mL of 0.2 mM Tribasic Sodium Phosphate after completion of acid stage); pH 6.8 (Method B) Acid stage: 750; Buffer stage: 1000 Acid stage: 60, 90 and 120; Buffer stage: 10, 20, 30, 45 and 60 2009/10/30
Paricalcitol Capsule I (Basket) 100 4 mg/mL (0.4%) Lauryldimethylamine N-oxide (LDAO) 500 20, 30, 45, 60 2007/06/18
Paromomycin Sulfate Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Paroxetine Tablet (Extended Release) Refer to USP 2015/11/19
Paroxetine HCl Suspension II (Paddle) 100 SGF without enzyme 900 10, 20, 30 and 45 2004/02/13
Paroxetine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Paroxetine Mesylate Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Paroxetine Mesylate Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Patisiran Sodium Solution II (Paddle) 25 Tris/EDTA buffer, pH 7.5 with 0.02% Tween 20 500 2, 5, 7, 11 and 15 2023/03/30
Pazopanib HCl Tablet II (Paddle) 75 50 mM Sodium Acetate buffer, pH 4.5, containing 0.75% SDS 900 10, 15, 30, 45 and 60 2010/08/05
Pemigatinib Tablet I (Basket) 50 0.01 N HCl 500 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18日。
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