阿米卡星生产过程中杂质E形成条件探讨及杂质控制策略

Discussion on Formation Conditions of Impurity E in Amikacin Production Process and Impurity Control Strategy

阿米卡星为半合成氨基糖甙类抗生素,以卡那霉素为起始物料通过一系列的合成而来,通过对过程控制方法的重新建立来有效监控各个杂质,包括杂质E。文章着重对杂质E进行研究,通过合成条件的摸索及杂质控制策略,找到杂质E的影响因素及杂质控制策略,取得了较理想的结果。

Amikacin is a semi synthetic aminoglycoside antibiotic,which is synthesized from kanamycin through a series of synthesis.Through the reestablishment of process control method,all impurities,including impurity E,can be effectively monitored.This study focuses on the study of impurity E.through the exploration of synthesis conditions and impurity control strategy,the influencing factors and impurity control strategy of impurity e are found,and the ideal results are obtained.