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
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
Omaveloxolone	Capsule	I (Basket)	100	50 mM Sodium Phosphate Buffer, pH 6.8	900	10, 15, 20, 30, 45 and 60	2024/05/31
Ombitasvir/ Paritaprevir/ Ritonavir and Dasabuvir Sodium	Tablet	II (Paddle)	75	Ombitasvir, paritaprevir, ritonavir: 0.05 M sodium phosphate buffer, pH 6.8 with 0.3% polyoxyethylene 10 lauryl ether; Dasabuvir sodium: 0.05 M Sodium Phosphate buffer, pH 6.8 with 15 mM cetyl triethylammonium bromide (CTAB)	900	Ombitasvir, paritaprevir, ritonavir: 10, 20, 30, 45, 60, 90, 120 and 150; Dasabuvir: 5, 10, 15, 20 and 30	2015/08/27
Ombitasvir/Paritaprevir/Ritonavir	Tablet	II (Paddle) with sinker	75	0.05M Sodium Phosphate Buffer, pH 6.8 with 0.3% (w/v) Polyoxyethylene 10 Lauryl Ether (POE10LE)	900	10, 20, 30, 45, 60, 90, 120, 150 and 180	2016/06/30