Ezetimibe Impurity 60 CAS 538-51-2

Description

Compared with other compounds in its class, the molecular weight of 181.23 g/mol gives Ezetimibe Impurity 60 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Ezetimibe Impurity 60 (CAS 538-51-2, C13H11N) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Ezetimibe Impurity 60 (C13H11N) contains a nitrogen-containing heterocyclic scaffold, a nitrile group. Its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

As a certified reference material (CRM), Ezetimibe Impurity 60 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

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