Pregabalin Impurity 59 CAS 53439-96-6

Description

Compared with other compounds in its class, the molecular weight of 194.23 g/mol gives Pregabalin Impurity 59 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Pregabalin Impurity 59 (CAS 53439-96-6) is a certified pharmaceutical impurity reference standard with the molecular formula C11H14O3 and a molecular weight of 194.23 g/mol.

Based on its molecular formula C11H14O3, Pregabalin Impurity 59 contains a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 194.23 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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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