Crisaborole Impurity 60 CAS CATO-C4X-202160

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Crisaborole Impurity 60.

CATO supplies Crisaborole Impurity 60 (CAS CATO-C4X-202160), a pharmacopoeial impurity reference standard (molecular formula C14H16BrNO2, MW 310.19 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Crisaborole Impurity 60 (C14H16BrNO2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, bromine substitution. The molecule exhibits a degree of unsaturation (DBE) of 7.0, corresponding to approximately 7 ring(s) or double-bond equivalent(s). With a molecular weight of 310.19 g/mol, it falls into the moderately-high-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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), Crisaborole Impurity 60 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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