Memantine Impurity 26 CAS 878-61-5

Description

The occurrence of Memantine Impurity 26 is closely related to bromine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Memantine Impurity 26 (CAS 878-61-5), a pharmacopoeial impurity reference standard (molecular formula C12H19Br, MW 243.18 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to bromine substitution, Memantine Impurity 26 is typically white to off-white low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 243.18 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

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