基因毒性杂质具有在极低暴露水平下即能导致严重毒性的特点，对用药的安全性造成严重的威胁。作为一类重要的基因毒性杂质，肼是一种常见的中间体，而且是常见药物的降解产物。对基因毒性杂质进行了概述，并较为详尽地介绍了肼类基因毒性杂质的分析方法，为需要测定此类基因毒性杂质的分析人员提供参考。

Genotoxic impurities can cause serious toxicity at very low exposure levels, which pose a serious threat to the medication safety. As an important genotoxic impurity, hydrazine is a common intermediate and a degradation product of common drugs. This article reviews the hydrazine genotoxic impurities and its analysis methods in detail, which intended to provide guidance for analyst needing to determine such genotoxic impurities.

R962.2