Structure Elucidation and Impurity Services
Regulatory agencies focus on the control of impurities, especially potential genotoxic impurities (PGIs), as a high priority in the drug development approval process. Since impurities found in pharmaceutical drug substances can exhibit potentially deleterious effects, there are reporting, identification, and qualification thresholds dictated by ICH guidelines. Impurity levels need to be well 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 timeline if not addressed early during the API scale up process.
Learn about elemental impurities, the new ICH Q3D and USP <232> and <233> guidelines, and our onsite ICP-MS testing here.