Adapalene EP Impurity D CAS 932033-57-3

Description

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

CATO supplies Adapalene EP Impurity D (CAS 932033-57-3), a pharmacopoeial impurity reference standard (molecular formula C34H42O2, MW 482.70 g/mol) used for the identification and quantification of trace impurities in APIs.

Adapalene EP Impurity D (C34H42O2) contains a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system. Its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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), Adapalene EP Impurity D 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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