Roflumilast Impurity 56 CAS CATO-C4X-108456

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Roflumilast Impurity 56.

CATO supplies Roflumilast Impurity 56 (CAS CATO-C4X-108456), a pharmacopoeial impurity reference standard (molecular formula C14H16F2O3S, MW 302.34 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C14H16F2O3S, Roflumilast Impurity 56 contains a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, an aromatic ring system; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 302.34 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

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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