Ezetimibe Impurity 9 CAS 163380-15-2

Description

As a process- or degradation-related impurity, Ezetimibe Impurity 9 (CAS 163380-15-2, C31H27F2NO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Ezetimibe Impurity 9 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 499.55 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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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