基因毒性雜質(zhì)具有在極低暴露水平下即能導(dǎo)致嚴(yán)重毒性的特點(diǎn)，對用藥的安全性造成嚴(yán)重的威脅。作為一類重要的基因毒性雜質(zhì)，肼是一種常見的中間體，而且是常見藥物的降解產(chǎn)物。對基因毒性雜質(zhì)進(jìn)行了概述，并較為詳盡地介紹了肼類基因毒性雜質(zhì)的分析方法，為需要測定此類基因毒性雜質(zhì)的分析人員提供參考。

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