Methylnaltrexone Bromide Impurity 12 CAS CATO-C4X-152112

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Methylnaltrexone Bromide Impurity 12.

CATO supplies Methylnaltrexone Bromide Impurity 12 (CAS CATO-C4X-152112), a pharmacopoeial impurity reference standard (molecular formula C21H26NO4, MW 356.44 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, Methylnaltrexone Bromide Impurity 12 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 356.44 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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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