Dexmedetomidine Impurity 46 CAS CATO-C4X-123046

Description

The occurrence of Dexmedetomidine Impurity 46 is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Dexmedetomidine Impurity 46 (CAS CATO-C4X-123046), a pharmacopoeial impurity reference standard (molecular formula C13H18O2, MW 206.28 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Dexmedetomidine Impurity 46 (C13H18O2) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), 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.

As a certified reference material (CRM), Dexmedetomidine Impurity 46 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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