美国FDA药品溶出方法数据库

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
Nitisinone	Tablet	II (Paddle)	50	Phosphate Buffer, pH 6.8	2 mg tablets: 500 mL; 5 mg and 10 mg tablets: 900 mL	10, 15, 20, 30, 45, 60, 75 and 90	2018/02/15
Nitisinone	Suspension	II (Paddle)	50	pH 1.2 HCl Buffer (degassed)	1000	10, 15, 20, 30 and 45	2016/12/22
Nitrofurantoin	Capsule			Refer to USP			2009/04/02
Nitrofurantoin	Suspension	II (Paddle)	50	Phosphate Buffer, pH 7.2	900	15, 30, 60, 120 and 180	2009/04/02
Nitroglycerin	Film, Extended Release	Modified USP Type V (Paddle-over-disk)	100	Deionized Water at 32º C	900	10, 20, 30, 45, 60, 90, 120 and 180	2010/04/08
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