Lefamulinum Impurity 14 CAS CATO-C4X-304714

Description

The occurrence of Lefamulinum Impurity 14 is closely related to a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Lefamulinum Impurity 14 (CAS CATO-C4X-304714) is a certified pharmaceutical impurity reference standard with the molecular formula C28H43NO5S and a molecular weight of 505.71 g/mol.

The molecular framework of Lefamulinum Impurity 14 (C28H43NO5S) is characterized by a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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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