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.
BioNH's 2019 Annual Dinner Meeting & Innovation CelebrationThe annual dinner meeting and innovation celebration will be attended by Masha Kononov, Senior Director Emerging Pharma US.
BioNH's 2019 Annual Dinner Meeting & Innovation CelebrationDates: 7th FebruaryLocation: New Brunswick, NJ
CED Life ScienceThe CED Life Science Conference will be attended by Masha Kononov, Senior Director Emerging Pharma US and Gail Frey, Senior Director Key Accounts US.
CED Life ScienceDates: 16th - 17th FebruaryLocation: Raleigh, NC
Drug Delivery & Formulation SummitThe DDF Summit 2019 will be attended by Dr. Nathalie Huther, Business Development Manager Europe.
Drug Delivery & Formulation SummitDates: 11th - 13th MarchLocation: Berlin, Germany