Methylprednisolone Impurity 78 CAS CATO-C4X-191978

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Methylprednisolone Impurity 78.

Methylprednisolone Impurity 78 (CAS CATO-C4X-191978) is a certified pharmaceutical impurity reference standard with the molecular formula C26H32O8 and a molecular weight of 472.53 g/mol.

Based on its molecular formula C26H32O8, Methylprednisolone Impurity 78 contains a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 472.53 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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), Methylprednisolone Impurity 78 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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