Isotretinoin EP Impurity F CAS 68070-35-9

Description

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

CATO supplies Isotretinoin EP Impurity F (CAS 68070-35-9), a pharmacopoeial impurity reference standard (molecular formula C20H28O2, MW 300.44 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Isotretinoin EP Impurity F (C20H28O2) is characterized by a steroid core, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), 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), Isotretinoin 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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