Our extensive knowledge and experience allows us to approach investigative analysis proactively and efficiently
Our dedicated cGMP-MS and NMR facility routinely performs the identification of degradation products found during stability testing, the impurities found during API and drug product testing, and metabolites found during bioanalysis. Structural elucidation and chemical characterization of compounds using MS, NMR and IR are carried out on a daily basis.
Our spectroscopy expertise combined with in-house synthetic chemistry knowledge can help determine the likely source of impurities. We also have the instrumentation and synthetic capabilities to isolate or manufacture samples of impurities that can be used as reference standards. Being part of an extensive discovery, development and manufacturing organization, we know the challenges which can arise and are on hand to tackle these with you at all times.