Insulin Degludec Impurity 6 CAS CATO-C4X-21576

Description

Compared with other compounds in its class, the molecular weight of 850.99 g/mol gives Insulin Degludec Impurity 6 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Insulin Degludec Impurity 6 (CAS CATO-C4X-21576), a pharmacopoeial impurity reference standard (molecular formula C42H66N4O14, MW 850.99 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Insulin Degludec Impurity 6 (C42H66N4O14) 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. 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 Insulin Degludec Impurity 6 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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