Betamethasone EP Impurity E CAS 981-34-0

Description

Compared with other compounds in its class, the molecular weight of 372.45 g/mol gives Betamethasone EP Impurity E distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Betamethasone EP Impurity E (CAS 981-34-0), a pharmacopoeial impurity reference standard (molecular formula C22H28O5, MW 372.45 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Betamethasone EP Impurity E (C22H28O5) is characterized by a flavonoid core, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

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