Dimetindene Maleate EP Impurity E Hydrochloride CAS 5143-99-7

Description

Compared with other compounds in its class, the molecular weight of 239.74 g/mol gives Dimetindene Maleate EP Impurity E Hydrochloride distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Dimetindene Maleate EP Impurity E Hydrochloride (CAS 5143-99-7), a pharmacopoeial impurity reference standard (molecular formula C13H17NOHCl, MW 239.74 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Dimetindene Maleate EP Impurity E Hydrochloride (C13H17NOHCl) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 5.0, corresponding to approximately 5 ring(s) or double-bond equivalent(s). With a molecular weight of 239.74 g/mol, it falls into the medium-molecular-weight range. 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), Dimetindene Maleate EP Impurity E Hydrochloride 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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