Regulatory & Consultancy

Potential Mutagenic Impurity (GTI) Assessments

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.