Iodixanol EP Impurity H CAS CATO-C4X-166312

Description

The occurrence of Iodixanol EP Impurity H is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, iodine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Iodixanol EP Impurity H (CAS CATO-C4X-166312), a pharmacopoeial impurity reference standard (molecular formula C54H68I9N9O23, MW 2353.30 g/mol) used for the identification and quantification of trace impurities in APIs.

Iodixanol EP Impurity H (C54H68I9N9O23) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, iodine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, 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 Iodixanol EP Impurity H 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?

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