Fluconazole EP Impurity H CAS 150194-52-8

Description

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

CATO supplies Fluconazole EP Impurity H (CAS 150194-52-8), a pharmacopoeial impurity reference standard (molecular formula C11H10BrF2N3O, MW 318.12 g/mol) used for the identification and quantification of trace impurities in APIs.

Fluconazole EP Impurity H (C11H10BrF2N3O) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine/bromine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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 Fluconazole 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

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