Fludarabine Phosphate EP Impurity E CAS 21679-14-1

Description

Compared with other compounds in its class, the molecular weight of 285.23 g/mol gives Fludarabine Phosphate EP Impurity E distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Fludarabine Phosphate EP Impurity E (CAS 21679-14-1), a pharmacopoeial impurity reference standard (molecular formula C10H12FN5O4, MW 285.23 g/mol) used for the identification and quantification of trace impurities in APIs.

Fludarabine Phosphate EP Impurity E (C10H12FN5O4) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine 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. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 Fludarabine Phosphate EP Impurity E 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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