Nefopam impurity 22 CAS CATO-C4X-283722

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Nefopam impurity 22.

CATO supplies Nefopam impurity 22 (CAS CATO-C4X-283722), a pharmacopoeial impurity reference standard (molecular formula C15H13NO2, MW 239.27 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Nefopam impurity 22 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 239.27 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), Nefopam impurity 22 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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