Empagliflozin Impurity 83(Mixture of Diastereomers) CAS CATO-C4X-106583

Description

Compared with other compounds in its class, the molecular weight of 158.19 g/mol gives Empagliflozin Impurity 83(Mixture of Diastereomers) distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Empagliflozin Impurity 83(Mixture of Diastereomers) (CAS CATO-C4X-106583), a pharmacopoeial impurity reference standard (molecular formula C8H14O3, MW 158.19 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Empagliflozin Impurity 83(Mixture of Diastereomers) (C8H14O3) contains a carboxylic acid group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 2.0, corresponding to approximately 2 ring(s) or double-bond equivalent(s). With a molecular weight of 158.19 g/mol, it falls into the medium-molecular-weight range.

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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