Apremilast Impurity 48 CAS 1450657-28-9

Description

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

Apremilast Impurity 48 (CAS 1450657-28-9) is a certified pharmaceutical impurity reference standard with the molecular formula C12H16O5S and a molecular weight of 272.32 g/mol.

The molecular framework of Apremilast Impurity 48 (C12H16O5S) is characterized by a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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), Apremilast 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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