ELEMENTAL, NITROSAMINES AND OTHER IMPURITIES TESTING
Kymos provides Elemental, Nitrosamines and other impurities testing of drug products, substances and other sources in compliance with ICH Q3D guidelines, EMA and FDA LoQs and recommendations. This impurities testing service targets clients interested in routine testing of finished dosage forms in drug products. Or those in need of identifying potential sources of impurities in drug substances, excipients, manufacturing equipment and reagents. We have significant analytical capacity with two ICP/MS and an AAS for elemental impurities plus HS-GC-MS and LC-MS/MS instruments for nitrosamines. The full service includes risk assessments with our strategic partner Azierta. We propose a three-step approach for impurities testing compliant with regulatory requirements:
