Palonosetron Impurity N64 CAS 135729-66-7

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Palonosetron Impurity N64.

CATO supplies Palonosetron Impurity N64 (CAS 135729-66-7), a pharmacopoeial impurity reference standard (molecular formula C19H22N2OHCl, MW 330.86 g/mol) used for the identification and quantification of trace impurities in APIs.

Palonosetron Impurity N64 (C19H22N2OHCl) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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), Palonosetron Impurity N64 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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