Genotoxic chemicals interact adversely with the genetic material, or DNA of cells. Genotoxicity testing is designed to idenitify drugs or impurities within those drugs that are capable of inducing genetic damage. Compounds identified as genotoxic in these tests have the potential to be human carcinogens and/or mutagens.
Genotoxic testing of new chemical entities is an integral part of the drug development process and a regulatory requirement prior to the approval of new drugs.
Smithers offers specific expertise in identification of Potential Genotoxic Impurities.