Nimodipine Impurity 15 CAS CATO-C4X-138515

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Nimodipine Impurity 15.

CATO supplies Nimodipine Impurity 15 (CAS CATO-C4X-138515), a pharmacopoeial impurity reference standard (molecular formula C42H52N4O10, MW 772.88 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C42H52N4O10, Nimodipine Impurity 15 contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 772.88 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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), Nimodipine Impurity 15 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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