阿托伐他汀环氧化物对照品，148146-51-4，5mg

描述

Catalogue Number ? ?A791855 ? ?Chemical Name ? ?Atorvastatin Epoxydione Impurity ? ?Synonyms ? ?3-(4-Fluorobenzoyl)-2-(2-methyl-1-oxopropyl)-N,3-diphenyloxiranecarboxamide; USP Atorvastatin Related Impurity D; Atorvastatin EP Impurity D; Atorvastatin epoxydione impurity ? ?Impurity ? ?Atorvastatin EP Impurity D ? ?CAS Number ? ?148146-51-4Molecular Formula ? ?C??H??FNO? ? ?Appearance ? ?White to Off-White Solid ? ?Melting Point ? ?179-182C ? ?Molecular Weight ? ?431.46 ? ?Storage ? ?4°C ? ?Solubility ? ?Acetonitrile (Slightly), Chloroform (Slightly, Heated, Sonicated), DMSO (Slightl ? ?Category ? ?Standards; Pharmaceutical/API Drug Impurities/Metabolites; ? ?Applications ? ?Atorvastatin Epoxydione Impurity (Atorvastatin EP Impurity D) is an Atorvastatin (A791750) impurity, an oxidative degradation products of Atorvastatin. ? ?References ? ?Roth, B., et al.: J. Med. Chem., 34, 357 (1991), Lea, A., et al.: Drugs, 53, 828 (1997), Black, A., et al.: Drug Metab. Dispos., 27, 916 (1999), ? ?

Atorvastatin 杂质及相关物质药物杂质是指药物中存在的无治疗作用或者影响药物的稳定性、疗效,甚至对人体的健康有害的物质；在药物的研究、生产、贮存和临床应用等方面,必须保持药物的纯度,降低药物的杂质,这样才能保证药物的有效性和安全性。通常可以将药物的结构、外观性状、理化常数、杂质检查和含量测定等方面作为一个相互关联的整体来评价药物的纯度。药物中含有的杂质是影响药物纯度的主要因素,如药物中含有超过限量的杂质,就有可能使理化常数变动,外观性状产生变异,并影响药物的稳定性；杂质增多也必然使药物的含量偏低或活性降低,毒副作用显著增加。