Genotoxic Impurities: A Regulatory Toxicology Commentary on Recent Articles in Organic Process Research & Development

Although it has now been over four years since the introduction of the EU guideline on limits of genotoxic impurities, even after various amendments the regulatory guidance is still associated with ambiguity and differing interpretations. In spite of this, it is believed that a critical toxicological analysis can shed light on a number of key issues ranging from the definition of a genotoxic impurity to the determination of appropriate limits and performing compound-specific risk assessments on the basis of public-domain data.