Ezetimibe Impurity 1 CAS 204589-58-2

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.204589-58-2
Molecular FormulaC24H21F2NO2
Molecular Weight393.43 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ezetimibe Impurity 1 CAS 204589-58-2 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 393.43 g/mol gives Ezetimibe Impurity 1 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Ezetimibe Impurity 1 (CAS 204589-58-2), a pharmacopoeial impurity reference standard (molecular formula C24H21F2NO2, MW 393.43 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C24H21F2NO2, Ezetimibe Impurity 1 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 393.43 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

As a certified reference material (CRM), Ezetimibe Impurity 1 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC24H21F2NO2
Molecular Weight393.43 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
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)14.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2015
Halogen ContentF-containing
Nitrogen Atoms1

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