Tramadol Hydrochloride EP Impurity C CAS 905592-54-3

Description

Compared with other compounds in its class, the molecular weight of 245.36 g/mol gives Tramadol Hydrochloride EP Impurity C distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Tramadol Hydrochloride EP Impurity C (CAS 905592-54-3), a pharmacopoeial impurity reference standard (molecular formula C16H23NO, MW 245.36 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Tramadol Hydrochloride EP Impurity C is typically off-white to pale yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 245.36 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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