Pharmaceutical Impurity Analysis and Identification Testing

Our GMP compliant laboratories provide pharmaceutical impurity testing for new drug substances (ICH Q3A(R2)) and new drug products (ICH Q3B(R2)) that can support your product development from an early stage and across the lifecycle of your drug product. Our scientists are adept at method routinely overcome the challenges of low detection levels and difficult matrices, providing analysis expertise for resolving extractables and leachables, elemental impurities testing, residual solvents (OVI or VOC) analysis or process-related impurities across all dosage forms, product classes and drug delivery technologies, including inhaled drug product development with strengths in highly sensitive and specific method development and validation expertise to address the determination of, and control over, genotoxic impurities such as nitrosamines.