Ezetimibe Impurity 5 CAS 1374250-07-3

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.1374250-07-3
Molecular FormulaC24H23F2NO2
Molecular Weight395.44 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ezetimibe Impurity 5 CAS 1374250-07-3 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 395.44 g/mol gives Ezetimibe Impurity 5 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Ezetimibe Impurity 5 (CAS 1374250-07-3) is a certified pharmaceutical impurity reference standard with the molecular formula C24H23F2NO2 and a molecular weight of 395.44 g/mol.

Based on its molecular formula C24H23F2NO2, Ezetimibe Impurity 5 contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 395.44 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 FormulaC24H23F2NO2
Molecular Weight395.44 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>90%
StorageStore at 2-8°C, protect from light
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)13.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1991
Halogen ContentF-containing
Nitrogen Atoms1

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