New standards in impurity testing are anticipated in the near future, aimed at strictly limiting substances possessing the potential for genotoxicity. The lead has been taken by the European Agency for the Evaluation of Medicinal Products (EMEA) which issued a guidance on genotoxic impurities effective January 1, 2007. A daily exposure limit of 1.5 ug has been sited for genotoxic impurities in most pharmaceuticals. This follows the precendent applicaion of the threshold of toxicological concern (TTC) concept to food additives and food contact materials. Click to download associated PDF file (courtesy of EMEA)

Before the EMEA draft guidance, genotoxic impurities had been addressed only as a footnote in ICH Q3A R2 “Impurities in New Drug Substances”. Click to download associated PDF file (courtesy of EMEA)

In the interim, the industry is waiting for the release of an FDA draft guidance on genotoxic impurities. We at Atlantic Analytical foresee the need to prepare for genotoxic impurities testing and can assist pharmaceutical and biotech manufacturers for these eventualities today.