Maprotiline EP impurity E HCl CAS 23941-45-9

Description

The occurrence of Maprotiline EP impurity E HCl is closely related to a nitrogen-containing heterocyclic scaffold, a nitrile group, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Maprotiline EP impurity E HCl (CAS 23941-45-9, C21H25NHCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a nitrogen-containing heterocyclic scaffold, a nitrile group, chlorine substitution, Maprotiline EP impurity E HCl is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 327.90 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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