Itraconazole Impurity 38 CAS 115897-54-6

Description

Compared with other compounds in its class, the molecular weight of 408.26 g/mol gives Itraconazole Impurity 38 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Itraconazole Impurity 38 (CAS 115897-54-6, C14H15Cl2N3O5S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Itraconazole Impurity 38 (C14H15Cl2N3O5S) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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), Itraconazole Impurity 38 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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