Difenidol Impurity 3 CAS 63645-18-1

Description

The occurrence of Difenidol Impurity 3 is closely related to a hydroxyl group, an ether linkage, chlorine substitution, a polycyclic aromatic system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Difenidol Impurity 3 (CAS 63645-18-1), a pharmacopoeial impurity reference standard (molecular formula C16H17ClO, MW 260.76 g/mol) used for the identification and quantification of trace impurities in APIs.

Difenidol Impurity 3 (C16H17ClO) contains a hydroxyl group, an ether linkage, chlorine substitution, a polycyclic aromatic system. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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