Rosuvastatin Impurity 267 CAS 1031246-43-1

Description

Compared with other compounds in its class, the molecular weight of 323.39 g/mol gives Rosuvastatin Impurity 267 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Rosuvastatin Impurity 267 (CAS 1031246-43-1), a pharmacopoeial impurity reference standard (molecular formula C15H18FN3O2S, MW 323.39 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Rosuvastatin Impurity 267 (C15H18FN3O2S) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine substitution. 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. 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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