头孢克洛结晶方法及产品质量研究

Crystallization Method and Product Quality of Cefaclor

对头孢克洛合成过程中的结晶技术进行研究,优化出一种新的结晶方法,并通过试验与另外两种结晶方法进行了全面数据对比,其主要质量指标、溶剂残留以及加速稳定性试验的数据明显优于其他结晶方法。其中单一杂质只有0.06%,而且只有1个杂质可检出。该结晶方法操作简单,节省工时,收率达87.4%,易于实现产业化。

A novel crystallization method for the synthesis of Cefaclor was obtained.Overall comparison between this experimental data and the data obtained through the other two crystallization methods proved that the main quality indicators,residual solvent,and accelerated stability test data of this novel method were obviously superior to those of the other methods.Only one impurity was observed with a content of 0.06%in the product.This method has advantages including simple operation,time saving and yield coefficient as high as 87.4%,easy application in industrial production.