Capecitabine Impurity 14 CAS 76497-54-6

Description

The occurrence of Capecitabine Impurity 14 is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Capecitabine Impurity 14 (CAS 76497-54-6), a pharmacopoeial impurity reference standard (molecular formula C11H16O7, MW 260.24 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Capecitabine Impurity 14 (C11H16O7) contains a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. The molecule exhibits a degree of unsaturation (DBE) of 4.0, corresponding to approximately 4 ring(s) or double-bond equivalent(s). With a molecular weight of 260.24 g/mol, it falls into the medium-molecular-weight range. 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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