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
Oteseconazole Capsule II (Paddle) with sinker 75 Tier 1: Stage 1: 0.01N HCl; Stage 2: After 15 minutes, add 150 mL of 3.0% SLS Tier 2: Stage 1: Pepsin (750,000 units/L) in 0.01N HCl; Stage 2: After 15 minutes, add 150 mL of 3.0% SLS 20, 30, 45 and 60 2023/10/06
Oxandrolone Tablet Refer to USP 2023/02/09
Oxaprozin Tablet Refer to USP 2016/03/17
Oxazepam Capsule Refer to USP 2024/05/31
Oxcarbazepine Tablet (Extended Release) Develop a dissolution method 2023/09/15
Oxcarbazepine Suspension Develop a dissolution method 2023/09/15
Oxcarbazepine Tablet Develop a dissolution method 2023/09/15
Oxybutynin Trans-dermal Paddle over Disk (Apparatus 5) 50 Phosphate Buffer, pH 4.5 @ 32oC 900 1, 4, 24 hours 2007/01/03
Oxybutynin Chloride Tablet (Extended Release) Refer to USP 2015/12/24
Oxycodone Capsule (Extended Release) I (Basket) 100 22 mM Sodium Acetate buffer, pH 4.5 with 0.03% Tween 20 900 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours 2016/07/28
Oxycodone HCl Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Oxycodone HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Oxycodone HCl Tablet (Extended Release) Refer to USP 2016/03/17
Oxycodone HCl/ Naloxone HCl Tablet (Extended Release) II (Paddle) 50 Simulated Gastric Fluid [SGF, pH 1.2] without enzyme 900 0.25, 0.5, 1, 2, 4, 6, 8, 10 and 12 hours 2016/12/22
Oxymorphone HCl Tablets Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Oxymorphone HCl Tablet (Extended Release) II (Paddle) with sinker 50 45 mM Phosphate Buffer, pH 4.5 900 1, 2, 4, 6, 8 and 10 hours 2014/02/14
Ozanimod HCl Capsule Refer to FDA's Dissolution Guidance, 2018 2022/05/12
Pacritinib Citrate Capsule II (Paddle) with sinker 75 0.08 M HCl/0.034 M NaCl, pH 1.2 900 5, 10, 15 and 30 2023/05/18
Palbociclib Capsule II (Paddle) with sinker 50 0.1 N HCl 900 10, 15, 20, 30 and 45 2016/03/17
Palbociclib Tablet II (Paddle) 75 0.1 N HCl 900 10, 15, 20, 30 and 45 2021/08/19

数据库说明:

当前数据更新日期:2025年12月19日。
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