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Impurity/Degradation Product Identification

The identification of drug impurities or their degradation products is an integral part of the drug development process. Impurities in drug substances and drug products typically arise from synthesis and/or are degradants. However, some impurities, which are highly reactive because of their structure, have the potential to interact with DNA.

A mutagenicity assessment must be performed for all confirmed impurity/degradant structures found during the scientific evaluation of investigational drug substances and products in order to comply with ICH M7 guidance.  Arcinova has the capability to arrange these assessments using a range of different software tools.

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. 

 

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