White Paper | Analytical Approaches For Control of Genotoxic Impurities
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, Head of Sales and Consulting, describes analytical approaches, with relevant case studies, for identification and quantification and control of genotoxic impurities.
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