Ambroxol impurity 61 CAS 104670-74-8

Description

Compared with other compounds in its class, the molecular weight of 230.06 g/mol gives Ambroxol impurity 61 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Ambroxol impurity 61 (CAS 104670-74-8, C8H8BrNO2) 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, bromine substitution, Ambroxol impurity 61 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 230.06 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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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