Ezetimibe Impurity 71 CAS CATO-C4X-109871

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-109871
Molecular FormulaC31H27F2NO3
Molecular Weight499.55 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ezetimibe Impurity 71 CAS CATO-C4X-109871 chemical structure

Description

The molecular framework of Ezetimibe Impurity 71 (C31H27F2NO3) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

CATO supplies Ezetimibe Impurity 71 (CAS CATO-C4X-109871), a pharmacopoeial impurity reference standard (molecular formula C31H27F2NO3, MW 499.55 g/mol) used for the identification and quantification of trace impurities in APIs.

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

Molecular FormulaC31H27F2NO3
Molecular Weight499.55 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)18.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms1

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