Chlorphenamine Impurity 31 CAS 872811-44-4

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Chlorphenamine Impurity 31.

As a process- or degradation-related impurity, Chlorphenamine Impurity 31 (CAS 872811-44-4, C16H20N2O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Chlorphenamine Impurity 31 is typically pale yellow to yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 256.35 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

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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