Posaconazole impurity 209 CAS CATO-C4X-1208209

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Posaconazole impurity 209.

As a process- or degradation-related impurity, Posaconazole impurity 209 (CAS CATO-C4X-1208209, C12H20N2OC2H2O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Posaconazole impurity 209 (C12H20N2OC2H2O4) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, 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 209 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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