Ezetimibe Impurity 125 CAS 439080-96-3

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.439080-96-3
Molecular FormulaC20H20FNO4
Molecular Weight357.38 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ezetimibe Impurity 125 CAS 439080-96-3 chemical structure

Description

Ezetimibe Impurity 125 (CAS 439080-96-3) is a certified pharmaceutical impurity reference standard with the molecular formula C20H20FNO4 and a molecular weight of 357.38 g/mol.

Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Ezetimibe Impurity 125 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 357.38 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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 FormulaC20H20FNO4
Molecular Weight357.38 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity≥95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
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)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2025
Halogen ContentF-containing
Nitrogen Atoms1

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