Identifying genotoxic impurities (Gls) early in the drug development process and limiting these at acceptable levels in the API or drug product, helps to reduce risks associated with drug safety and quality. Epoxides are highly reactive and known to be potential genotoxic impurities.

In this case study, Dr Tino Otte, Head of Sales and Consulting, describes an analytical approach involving several technologies including NMR and LC-MS in order to investigate, identify, quantify and control epoxide genotoxic impurities in extracts from a sample of tablets.

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