Ambroxol Impurity 49 HCl CAS CATO-C4X-108549

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Ambroxol Impurity 49 HCl.

CATO supplies Ambroxol Impurity 49 HCl (CAS CATO-C4X-108549), a pharmacopoeial impurity reference standard (molecular formula C13H16Br2N2OHCl, MW 412.55 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C13H16Br2N2OHCl, Ambroxol Impurity 49 HCl contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine/bromine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 412.55 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.

CATO manufactures Ambroxol Impurity 49 HCl under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

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