Ezetimibe Impurity 117 CAS 1013025-04-1

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1013025-04-1
Molecular FormulaC25H24FNO5
Molecular Weight437.46 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ezetimibe Impurity 117 CAS 1013025-04-1 chemical structure

Description

CATO supplies Ezetimibe Impurity 117 (CAS 1013025-04-1), a pharmacopoeial impurity reference standard (molecular formula C25H24FNO5, MW 437.46 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Ezetimibe Impurity 117 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 437.46 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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 117 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 FormulaC25H24FNO5
Molecular Weight437.46 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)14.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1988
Halogen ContentF-containing
Nitrogen Atoms1

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