Mexiletine EP Impurity D(Enantiomer Mixture) CAS 26583-71-1

Description

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.

Mexiletine EP Impurity D(Enantiomer Mixture) (CAS 26583-71-1) is a certified pharmaceutical impurity reference standard with the molecular formula C11H17NO and a molecular weight of 179.26 g/mol.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Mexiletine EP Impurity D(Enantiomer Mixture) is typically off-white to pale yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 179.26 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

As a certified reference material (CRM), Mexiletine EP Impurity D(Enantiomer Mixture) 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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