Ciclopirox EP Impurity C CAS 67587-24-0

Description

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

CATO supplies Ciclopirox EP Impurity C (CAS 67587-24-0), a pharmacopoeial impurity reference standard (molecular formula C12H17, MW 191.27 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Ciclopirox EP Impurity C (C12H17) contains an aromatic ring system. The molecule exhibits a degree of unsaturation (DBE) of 4.5, corresponding to approximately 4 ring(s) or double-bond equivalent(s). With a molecular weight of 191.27 g/mol, it falls into the medium-molecular-weight range. 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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

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