Ezetimibe Impurity 44 CAS 204589-82-2

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.204589-82-2
Molecular FormulaC25H22FNO4
Molecular Weight419.44 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ezetimibe Impurity 44 CAS 204589-82-2 chemical structure

Description

As a certified reference material (CRM), Ezetimibe Impurity 44 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.

CATO supplies Ezetimibe Impurity 44 (CAS 204589-82-2), a pharmacopoeial impurity reference standard (molecular formula C25H22FNO4, MW 419.44 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Ezetimibe Impurity 44 (C25H22FNO4) is characterized by a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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.

Physical & Chemical Properties

Molecular FormulaC25H22FNO4
Molecular Weight419.44 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at room temperature, 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)15.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2015
Halogen ContentF-containing
Nitrogen Atoms1

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