Cinitapride Impurity 10 CAS CATO-C4X-290810

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Cinitapride Impurity 10.

CATO supplies Cinitapride Impurity 10 (CAS CATO-C4X-290810), a pharmacopoeial impurity reference standard (molecular formula C17H30N2O2, MW 294.43 g/mol) used for the identification and quantification of trace impurities in APIs.

Cinitapride Impurity 10 (C17H30N2O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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), Cinitapride Impurity 10 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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