CMC

Impurity/Degradation Product Identification

The identification of drug impurities or their degradation products is an integral part of the drug development process.

Linked to our expertise in chromatographic separation/isolation, on-site high field NMR, accurate mass spectrometry and synthetic capabilities, Arcinova scientists can offer a complete service for the identification and if relevant, chromatographic response factor determination, for impurities and degradation products of concern. This service can be accessed on a stand-alone basis or as part of an integrated CMC service.  

Chromatographic Development Case Study