Difelikefalin Impurity 89 CAS CATO-C4X-304189

Description

The occurrence of Difelikefalin Impurity 89 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.

Difelikefalin Impurity 89 (CAS CATO-C4X-304189) is a certified pharmaceutical impurity reference standard with the molecular formula C47H71N7O10 and a molecular weight of 894.11 g/mol.

The molecular framework of Difelikefalin Impurity 89 (C47H71N7O10) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 Difelikefalin Impurity 89 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

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