Impurity Services

Regulatory agencies have acknowledged impurities, especially potential genotoxic impurities (PGIs), as a high priority in the drug development approval process. Since impurities found in pharmaceutical drug substances can potentially exhibit pharmacological activity, there are reporting, identification, and qualification thresholds dictated by ICH guidelines. Impurity levels need to be understood and  controlled for the benefit of safely  administering pharmaceutical products to humans. Impurities impact not only the safety of drugs, but also the development time if not addressed early during the scale-up process.