Identifying genotoxic impurities early in the drug development process and limiting genotoxic impurities (Gls) at acceptable levels in the API or drug product, helps to reduce risks associated with drug safety and quality. With the implementation of increasingly stringent regulations for impurity levels, it is more important than ever for drug manufacturers to employ effective strategies for identifying, quantifying, and controlling GIs in their products.

In this white paper, Dr Tino Otte, Sales Director at Intertek Pharmaceutical Services, describes analytical approaches, with relevant case studies, for identification and quantification and control of genotoxic impurities.

Please complete the form to download our white paper on analytical approaches for control of genotoxic impurities:

 

Switzerland Analytical Laboratory

Intertek's Swiss analytical laboratory provides advanced lab testing to GLP/GMP standards for the pharmaceutical and medical device sectors