坎地沙坦酯中的潜在基因毒性杂质控制浅析

摘要

The decision of potential genotoxic impurities is based on the structural alerts. After the anal-ysis of potential geotaxis impurities arise in the synthesis route of API candesartan cilexetil, the control limits for such impurities were established. And then the controlling of bromine cyanobiphenyl impurity was given as an example to explain the way of potential geotaxic impurities control.%以警示结构为判断依据，首先分析了原料药坎地沙坦酯的合成工艺中的潜在基因毒性杂质，然后建立了这类杂质的控制限度要求，最后通过举例其中的溴氰基联苯杂质的控制来阐述这类杂质的控制方法。