Dabigatran Impurity 19 CAS 1416446-40-6

Description

Compared with other compounds in its class, the molecular weight of 571.63 g/mol gives Dabigatran Impurity 19 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Dabigatran Impurity 19 (CAS 1416446-40-6), a pharmacopoeial impurity reference standard (molecular formula C30H33N7O5, MW 571.63 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, Dabigatran Impurity 19 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 571.63 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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 Dabigatran Impurity 19 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