Genotoxic Impurities ID and Quantification

Identification and quantification of genotoxic impurities: To reduce drug safety and quality risks, diagnosing and limiting genotoxic impurities early on in drug development can reduce risk associated with genotoxic impurities. With the implementation of increasingly stringent regulations for impurity levels, our team provide effective strategies for identifying, quantifying, and controlling GIs in products. We are experienced in testing for the "cohort of concern" including nitrosamines impurities in pharma products and other potentially high potency mutagenic carcinogens which can be considered to have “alerting structures” and also includes aflatoxin-like-, and alkyl-azoxy compound. We provide screening, identification, method dev/val to GMP and quantification and tox risk assessments.

To learn more, visit our website:

www.intertek.com/pharmaceutical/gmp-cmc-laboratory/genotoxic-impurities-analysis