摘要
为了完善头孢地尼原料药的质量控制,建立其质量标准,从头孢地尼的合成路线入手,分析并合成其中可能存在的5种杂质:噻唑乙酰基甘氨酸肟、杂质O、杂质D、杂质G和杂质S,并经核磁共振氢谱和质谱确认。纯度经高效液相色谱法测定均达到了99%以上,可作为头孢地尼药物质量控制的杂质对照品,为头孢地尼产业化开发及质量控制提供依据。
To improve the quality control of Cefdinir API and establish its quality criteria,the preparation method for Cefdinir was analyzed and five related impurities(Thiazolylacetyl glycine oxime,impurity O,impurity D,impurity G,and impurity S)were synthesized and characterized by 1H NMR and Ms.The purities of related substances obtained by HPLC detection were over 99%,and can be used as impurity reference substances for the quality control of Cefdinir,which provides a basis for the industrial development and quality control of Cefdinir.
作者
王静
吴丹
刘龙
WANG Jing;WU Dan;LIU Long(Taizhou Medical Hi-Tech Development Public Services Platform, Taizhou 225300, China;School of Pharmaceutical Sciences, Guangzhou Medical University, Guangzhou 511436, China;Tianjin Best Peptide Pharmaceutical Technology Co., Ltd., Tianjin 300000, China)
出处
《山东科学》
CAS
2021年第2期42-47,共6页
Shandong Science
基金
职业危害识别与控制湖北省重点实验室开放基金(OHIC2020Y06)。
关键词
头孢地尼
头孢菌素
杂质
合成
Cefdinir
Cephalosporin
impurity
synthesis
