Darifenacin Impurity 3 CAS CATO-C4X-16053

Description

Compared with other compounds in its class, the molecular weight of 309.36 g/mol gives Darifenacin Impurity 3 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Darifenacin Impurity 3 (CAS CATO-C4X-16053) is a certified pharmaceutical impurity reference standard with the molecular formula C18H19N3O2 and a molecular weight of 309.36 g/mol.

The molecular framework of Darifenacin Impurity 3 (C18H19N3O2) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage. 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), Darifenacin Impurity 3 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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