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Potential Mutagenic Impurity (GTI) Assessments

Using a range of different software tools, Arcinova has the necessary expertise to assess the mutagenic potential of impurities and degradation products from drug substance and drug product manufacture, which is required for successful regulatory submissions and to comply with ICH M7 guidance, 

Some impurities, which are highly reactive because of their structure, have the potential to interact with DNA.

 

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