Dexmedetomidine Impurity 12 CAS 2240179-65-9

Description

The occurrence of Dexmedetomidine Impurity 12 is closely related to a nitrogen-containing heterocyclic scaffold, a nitrile group in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Dexmedetomidine Impurity 12 (CAS 2240179-65-9), a pharmacopoeial impurity reference standard (molecular formula C23H28N2, MW 332.48 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a nitrogen-containing heterocyclic scaffold, a nitrile group, Dexmedetomidine Impurity 12 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 332.48 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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