Cholecalciferol Impurity 18 CAS CATO-C4X-158618

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Cholecalciferol Impurity 18.

As a process- or degradation-related impurity, Cholecalciferol Impurity 18 (CAS CATO-C4X-158618, C27H46O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Based on its molecular formula C27H46O3, Cholecalciferol Impurity 18 contains a steroid core, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 418.65 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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