The last decade has seen continued development and refinement of guidance related to mutagenic impurities (MIs); culminating in June 2014 with the publication of ICH M7. This has seen an introduction of factors such as durationally adjusted limits and emergence of alternative approaches to demonstrate control, such as purge factor calculations, Teasdale et al.

This review examines the impact of these changes on the approaches taken to the analysis of MIs. Observed is the emergence of platform approaches; methods that can be applied to a class of MIs rather than simply to individual analytes. Another observation and concern is the continued development of highly specific sensitive methods for analytes, where appropriate knowledge of the status of the analyte (i.e. it is actually non-mutagenic), would have precluded the necessity to do so. This illustrates the need to conduct a thorough review of the available literature before analytical method development is commenced.

在过去的十年中，与诱变杂质（MIs）有关的指南不断发展和完善；ICH M7于2014年6月达到顶峰。这已经引入了一些因素，例如持续调整的限值，并出现了替代方法来证明控制效果，例如吹扫因子的计算，Teasdale等。

这次审查检查了这些变化对MIs分析方法的影响。可以观察到平台方法的出现；可以应用于一类MI的方法，而不是简单地应用于单个分析物的方法。另一个观察和关注的问题是对分析物的高度特异性敏感方法的持续发展，在这种情况下，如果对分析物的状态（即，实际上是非诱变的）有适当的了解，就不必这样做了。这说明在开始开发分析方法之前，需要对可用文献进行彻底的审查。