Nefopam impurity 14 CAS CATO-C4X-283714

Description

The occurrence of Nefopam impurity 14 is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Nefopam impurity 14 (CAS CATO-C4X-283714, C16H16N2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Nefopam impurity 14 (C16H16N2O2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 10.0, corresponding to approximately 10 ring(s) or double-bond equivalent(s). With a molecular weight of 268.31 g/mol, it falls into the medium-molecular-weight range. 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