Agomelatine Impurity 9 CAS CATO-C4X-11089

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Agomelatine Impurity 9.

Agomelatine Impurity 9 (CAS CATO-C4X-11089) is a certified pharmaceutical impurity reference standard with the molecular formula C26H26N2O2 and a molecular weight of 398.50 g/mol.

Structurally, Agomelatine Impurity 9 (C26H26N2O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 15.0, corresponding to approximately 15 ring(s) or double-bond equivalent(s). With a molecular weight of 398.50 g/mol, it falls into the moderately-high-molecular-weight range. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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), Agomelatine Impurity 9 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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