Varenicline Impurity  C61 CAS 357424-12-5

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Varenicline Impurity  C61.

CATO supplies Varenicline Impurity  C61 (CAS 357424-12-5), a pharmacopoeial impurity reference standard (molecular formula C12H13N3, MW 199.25 g/mol) used for the identification and quantification of trace impurities in APIs.

Varenicline Impurity  C61 (C12H13N3) contains a nitrogen-containing heterocyclic scaffold, a nitrile group. Its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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), Varenicline Impurity  C61 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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