(382z) Study on Separation and Transformation of Cefuroxime Axeomer

Abstract:The cefuroxime axetil, a prodrug of cefuroxime, is composed of a pair of diastereomers A and B isomers, and other substances are also mostly diastereomers. The presence of impurities not only reduces the purity of the drug, but also affects the stability of the drug and endangers the health of the human body. Therefore, we need to reduce the content of impurities to meet the Pharmacopoeia regulations or even better.

The purpose of this paper is to reduce the content of δ-3 impurities in cefuroxime axetil. It is proposed to investigate the change of δ-3 impurity content by changing the type and amount of lysing agent, rotation speed , temperature reflex and crystal growth time by means of precipitation crystallization. During the crystallization process, the ratio of the main components A and B isomers of cefuroxime axetil is changed. According to the literature, the bioavailability of the A and B isomers is different, and their respective configurations have not been determined so the content of the head δ-3 impurity is lowered. The A and B isomers were separated under the premise, and their configurations were determined to finally prepare a single isomer with high availability.