Fingolimod Impurity 28 CAS 162358-07-8

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Fingolimod Impurity 28.

CATO supplies Fingolimod Impurity 28 (CAS 162358-07-8), a pharmacopoeial impurity reference standard (molecular formula C16H25I, MW 344.27 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C16H25I, Fingolimod Impurity 28 contains iodine substitution, an aromatic ring system; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 344.27 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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), Fingolimod Impurity 28 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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