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
Nitroglycerin Tablet (Sublingual) II (Paddle) 50 Phosphate Buffer, pH 6.5 500 1, 3, 5, 8, and 10 2010/01/15
Nizatidine Capsule Develop a dissolution method 2024/01/03
Norethindrone Tablet Refer to USP 2009/10/08
Norethindrone Acetate Tablet Refer to USP 2009/08/27
Norgestrel Tablet Refer to FDA's Dissolution Guidance, 2018 2025/06/23
Nortriptyline HCl Capsule Develop a dissolution method 2024/01/03
Nystatin Oral Suspension Develop a dissolution method 2023/09/15
Nystatin Tablet Develop a dissolution method 2023/09/15
Obeticholic Acid Tablet II (Paddle) 75 0.08% polysorbate 80 in 50mM sodium phosphate dibasic buffer, pH 6.8 900 5, 10, 15, 20, 30 and 45 2017/11/02
Octreotide Acetate Capsule (Delayed Release) II (Paddle with sinker) 50 Acid stage: 0.1N HCl ; Buffer stage: pH 6.8 buffer Acid stage: 900; Buffer stage: 900 Acid stage: 120; Buffer stage: 10, 20, 30 45 and 60 2021/04/22
Octreotide Injection Injectable (Extended Release) Develop a dissolution method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency 2010/12/23
Ofloxacin Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Olanzapine Tablet Refer to FDA's Dissolution Guidance, 2018 2020/07/02
Olanzapine Tablet (Orally Disintegrating) Refer to USP 2015/01/15
Olanzapine Pamoate For Intramuscular Suspension (Extended Release) IV (Flow through cell), 22.6 mm cell Flow @ 3 mL/min 1% SLS in pH 6.8 Phosphate Buffer use Open Mode 10, 20, 30, 45, 60, 75, 90, 105, 120, 150, 180, 240, 360, 480, 600, and 720 2015/12/24
Olanzapine; Samidorphan L-malate Tablet Refer to FDA's Dissolution Guidance, 2018 2023/05/18
Olaparib Tablet I (Basket) 100 50 mM Phosphate Buffer, pH 6.8 900 15, 30, 45 and 60 2024/02/16
Olmesartan Medoxomil Tablet Refer to USP 2017/11/02
Olsalazine Sodium Capsule I (Basket) 100 Phosphate Buffer, pH 7.5 900 10, 20, 30 and 45 2004/02/12
Olutasidenib Capsule II (Paddle) with sinkers 65 McIlvaine Buffer, pH 2.2 W/ 1.25% SDS 500 10, 15, 30, 45, and 60 2024/02/05

数据库说明:

当前数据更新日期:2026年02月09日。
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