The synthesis of drug substances involves the use of reactive chemicals, reagents, solvents, catalysts, and other processing aids. As a result of chemical synthesis or subsequent degradation, impurities reside in all drug substances and associated drug products.

The ICH M7 guideline provides a practical framework that helps identify, categorize, qualify, and control such mutagenic impurities to limit potential carcinogenic risk.

SAXOCON’s competences and our access to approved software allows us to provide fully ICH M7-compliant assessments, including:

• Database and literature searches for carcinogenicity and bacterial mutagenicity data
• Screening using the Genetox Expert Alerts Suite (expert rule-based system)
• Screening using the Statistical QSAR Model (statistical system)
• A summary of the output from both systems – delivered in agreed report

Delivery

Upon completion of a screening, SAXOCON will discuss the results with the client to confirm which expert opinion is needed for the predictions.

Assessments follow the ICH M7 (R2) guidelines for evaluating of potential genotoxic impurities and the OECD Principles for validating QSAR models (ENV/JM/MONO(2006)25 Annex).

SAXOCON compiles all necessary documentation in a quality-controlled report.

For a quote, please contact Helen Friis-Mikkelsen.