Memantine Impurity 65 CAS CATO-C4X-105865

Description

Compared with other compounds in its class, the molecular weight of 195.30 g/mol gives Memantine Impurity 65 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Memantine Impurity 65 (CAS CATO-C4X-105865, C12H21NO) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Memantine Impurity 65 (C12H21NO) contains 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. 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), Memantine Impurity 65 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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