pregabalin Impurity 41 CAS CATO-C4X-131241

Description

The occurrence of pregabalin Impurity 41 is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies pregabalin Impurity 41 (CAS CATO-C4X-131241), a pharmacopoeial impurity reference standard (molecular formula C12H22O3, MW 214.31 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C12H22O3, pregabalin Impurity 41 contains a carboxylic acid group, a hydroxyl group, an ether linkage; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 214.31 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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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