Posaconazole impurity 221 CAS CATO-C4X-1208221

Description

The occurrence of Posaconazole impurity 221 is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Posaconazole impurity 221 (CAS CATO-C4X-1208221, C37H42F2N8O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Posaconazole impurity 221 (C37H42F2N8O4) 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. 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.

As a certified reference material (CRM), Posaconazole impurity 221 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

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