Macitentan Impurity 45 CAS CATO-C4X-117545

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Macitentan Impurity 45.

CATO supplies Macitentan Impurity 45 (CAS CATO-C4X-117545), a pharmacopoeial impurity reference standard (molecular formula C10H8BrClN4O2S, MW 363.62 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Macitentan Impurity 45 (C10H8BrClN4O2S) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine/bromine 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. 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

Why CATO?

• ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
• 130,000+ catalog items in stock, COA supplied with every batch
• Worldwide shipping with full export documentation (HS code guidance available)
• Technical support: +86 18665070610 / Nicole.chen@cato-chem.com