Ketoprofen Impurity 48 CAS 781-35-1

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Ketoprofen Impurity 48.

Ketoprofen Impurity 48 (CAS 781-35-1) is a certified pharmaceutical impurity reference standard with the molecular formula C15H14O and a molecular weight of 210.27 g/mol.

Owing to a hydroxyl group, an ether linkage, a polycyclic aromatic system, Ketoprofen Impurity 48 is typically pale yellow to yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 210.27 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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), Ketoprofen Impurity 48 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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