Lemborexant Impurity 45 CAS CATO-C4X-304245

Description

The occurrence of Lemborexant Impurity 45 is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, an aromatic ring system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Lemborexant Impurity 45 (CAS CATO-C4X-304245, C11H11FO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Lemborexant Impurity 45 (C11H11FO2) contains a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, an aromatic ring system. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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), Lemborexant Impurity 45 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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