Impurity qualification services for the Pharmaceutical and Medical Devices industries, following the ICH guidelines. Our expertise in this area enables us to provide the following:

• Impurity profiling by a thorough analysis of various impurity types, including process-related impurities, degradation products, and potential contaminants

• Human health risk assessment for the identified impurities

• Toxicological risk assessment of potentially genotoxic impurities in pharmaceutical products

• Use of the ‘threshold of toxicological concern (TTC)’ approach for qualifying genotoxic impurities