Cefdinir Impurity 53 CAS 178422-40-7

Description

Compared with other compounds in its class, the molecular weight of 246.24 g/mol gives Cefdinir Impurity 53 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Cefdinir Impurity 53 (CAS 178422-40-7) is a certified pharmaceutical impurity reference standard with the molecular formula C7H10N4O4S and a molecular weight of 246.24 g/mol.

Owing to an amide group, a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system, Cefdinir Impurity 53 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 246.24 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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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