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
Ondansetron HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Opicapone Capsule I (Basket with sinker) 100 Tier 1: 0.05 M Phosphate Buffer, pH 6.8 with 1% cetrimide; Tier 2: Stage 1: 0.05 M Phosphate Buffer, pH 6.8 with pancreatin (1750 USP units/L); Stage 2: after 10 minutes of Stage 1, add 100 mL of 10% cetrimide. 5, 10, 15, 20, 30 and 45 2022/05/12
Orlistat Capsule II (Paddle) 75 3% SLS in 0.5% Sodium Chloride, pH 6.0 900 10, 20, 30, 45 and 60 2004/02/12
Orphenadrine Citrate Tablet (Extended Release) Develop a dissolution method 2024/01/03
Oseltamivir Phosphate Oral Suspension II (Paddle) 25 0.1 N HCl 900 5, 10, 15, 20 and 30 2009/07/15
Oseltamivir Phosphate Capsule Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Osilodrostat Phosphate Tablet Refer to FDA's Dissolution Guidance, 2018 2021/08/19
Osimertinib Mesylate Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Ospemifene Tablet Develop a dissolution method 2023/09/15
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 Suspension Develop a dissolution method 2023/09/15
Oxcarbazepine Tablet Develop a dissolution method 2023/09/15
Oxcarbazepine Tablet (Extended Release) Develop a dissolution method 2023/09/15
Oxybutynin Film, Extended Release 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

数据库说明:

当前数据更新日期:2026年04月20日。
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