Residual Genotoxic Impurity Studies

Genotoxicity refers to any potential damage to DNA or the chromosomal structure which may result in mutation or cancer even at extremely low levels. Identification of genotoxic impurities at initial stage of drug development may help in prevention of potential damage and avoid risks associated with drug safety and quality in later stages of drug development cycle. The analysis of genotoxic impurities is important for addressing the purity, quality and safety of the drug substances or finished formulations. Though various regulatory bodies have defined the levels of impurities in drug substances and products, their determination at ultra-trace levels requires highly specific analytical approach.

At VIMTA, we have the capabilities to detect the genotoxic impurities even at extremely low levels. Our GCP, GMP and GLP compliant laboratories help in detection of genotoxic impurities and evaluate their potential hazards on APIs or finished products.