Dexmedetomidine Impurity 42 CAS CATO-C4X-123042

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Dexmedetomidine Impurity 42.

CATO supplies Dexmedetomidine Impurity 42 (CAS CATO-C4X-123042), a pharmacopoeial impurity reference standard (molecular formula C13H16N2O2, MW 232.28 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Dexmedetomidine Impurity 42 (C13H16N2O2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 7.0, corresponding to approximately 7 ring(s) or double-bond equivalent(s). With a molecular weight of 232.28 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), Dexmedetomidine Impurity 42 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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