Darifenacin Impurity 5 CAS CATO-C4X-16055

Description

Compared with other compounds in its class, the molecular weight of 309.36 g/mol gives Darifenacin Impurity 5 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Darifenacin Impurity 5 (CAS CATO-C4X-16055), a pharmacopoeial impurity reference standard (molecular formula C18H19N3O2, MW 309.36 g/mol) used for the identification and quantification of trace impurities in APIs.

Darifenacin Impurity 5 (C18H19N3O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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 Darifenacin Impurity 5 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)
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