Ibrutinib Impurity 80 CAS 109384-19-2

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Ibrutinib Impurity 80.

CATO supplies Ibrutinib Impurity 80 (CAS 109384-19-2), a pharmacopoeial impurity reference standard (molecular formula C10H19NO3, MW 201.26 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C10H19NO3, Ibrutinib Impurity 80 contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 201.26 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 Ibrutinib Impurity 80 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