Venlafaxine EP Impurity A HCl CAS 50822-98-5

Description

Compared with other compounds in its class, the molecular weight of 215.72 g/mol gives Venlafaxine EP Impurity A HCl distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Venlafaxine EP Impurity A HCl (CAS 50822-98-5) is a certified pharmaceutical impurity reference standard with the molecular formula C11H17NOHCl and a molecular weight of 215.72 g/mol.

Structurally, Venlafaxine EP Impurity A HCl (C11H17NOHCl) contains an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 3.0, corresponding to approximately 3 ring(s) or double-bond equivalent(s). With a molecular weight of 215.72 g/mol, it falls into the medium-molecular-weight range. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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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