Our Genotoxic Impurity Studies are designed to assess the genotoxic potential of impurities in pharmaceutical products, ensuring that they meet stringent regulatory safety standards. These studies are essential for evaluating the safety of active pharmaceutical ingredients (APIs), intermediates, and final drug products.

We utilize state-of-the-art analytical techniques to detect and quantify genotoxic impurities to support:

• Risk assessment and safety evaluation
• Regulatory compliance with ICH M7, FDA, and EMA guidelines
• Genotoxicity testing to ensure the safety of drug products
• Thresholds of toxicological concern (TTC) determination

Our testing protocols include the use of validated methods such as LC-MS/MS (Liquid Chromatography-Tandem Mass Spectrometry) and PCR-based assays to accurately identify and quantify potential genotoxic impurities, ensuring that your product is safe for use and compliant with regulatory requirements.