Flucloxacillin EP Impurity B CAS CATO-C4X-16472

Description

The occurrence of Flucloxacillin EP Impurity B is closely related to a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Flucloxacillin EP Impurity B (CAS CATO-C4X-16472) is a certified pharmaceutical impurity reference standard with the molecular formula C18H19ClFN3O4S and a molecular weight of 427.88 g/mol.

Structurally, Flucloxacillin EP Impurity B (C18H19ClFN3O4S) contains a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 10.0, corresponding to approximately 10 ring(s) or double-bond equivalent(s). With a molecular weight of 427.88 g/mol, it falls into the moderately-high-molecular-weight range. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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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