Prilocaine impurity 54 CAS CATO-C4X-193454

Description

Compared with other compounds in its class, the molecular weight of 234.34 g/mol gives Prilocaine impurity 54 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Prilocaine impurity 54 (CAS CATO-C4X-193454, C14H22N2O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Prilocaine impurity 54 (C14H22N2O) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. 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), Prilocaine impurity 54 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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