Epinastine Impurity 44 Fumarate CAS 127785-96-0

Description

Compared with other compounds in its class, the molecular weight of 340.38 g/mol gives Epinastine Impurity 44 Fumarate distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Epinastine Impurity 44 Fumarate (CAS 127785-96-0), a pharmacopoeial impurity reference standard (molecular formula C15H16N2C4H4O4, MW 340.38 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, Epinastine Impurity 44 Fumarate is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 340.38 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 44 Fumarate 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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