Pharma companies are now required to assess the potential genotoxic impurities (GTI) in their API and drug products, which must comply with regulations that limit patient exposure to certain impurities to as low as 1.5 µg/day. IAS assists the customer in identifying the potential GTI in the process and developing and validating a sensitive analytical method for their control. IAS also provides Quantitative Structure-Activity Relationship (QSAR) methodologies by software that predict the outcome of a bacterial mutagenicity assay as per ICH guidelines.

Genotoxic Evaluation and Studies