Epinastine Impurity 51 CAS CATO-C4X-184051

Description

The occurrence of Epinastine Impurity 51 is closely related to a nitrogen-containing heterocyclic scaffold, a nitrile group in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Epinastine Impurity 51 (CAS CATO-C4X-184051, C15H12N2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a nitrogen-containing heterocyclic scaffold, a nitrile group, Epinastine Impurity 51 is typically pale yellow to yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 220.27 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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), Epinastine Impurity 51 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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