Amorolfine EP Impurity F CAS 106614-66-8

Description

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

CATO supplies Amorolfine EP Impurity F (CAS 106614-66-8), a pharmacopoeial impurity reference standard (molecular formula C14H20O, MW 204.31 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C14H20O, Amorolfine EP Impurity F contains a hydroxyl group, an ether linkage, an aromatic ring system; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 204.31 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), Amorolfine EP Impurity F 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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