Osimertinib — impurities and related standards

All 3 Osimertinib-related compounds in the CATO catalogue, listed with their CAS numbers, molecular formulae and stock status. If the compound you need is not listed, send the structure or the impurity designation and we will check whether it can be synthesised or isolated.

Osimertinib is an orally administered, irreversible inhibitor of mutant epidermal growth factor receptor tyrosine kinase activity, used in the treatment of non-small cell lung cancer that carries activating EGFR mutations. Its impurity profile is shaped by a multi-step synthesis and by an acrylamide functionality that can react or hydrolyse, so laboratories examine process impurities and intermediates, degradation products formed under stress, and potential genotoxic impurities linked to the synthetic sequence. The osimertinib items collected here are non-compendial impurities, provided as individual characterised lots. They are intended for process-impurity identification, forced-degradation and stability studies, and the development of chromatographic methods for the drug substance and its oral formulations.

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