Ezetimibe Impurity N38 CAS 1510820-22-0

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1510820-22-0
Molecular FormulaC24H23F2NO2
Molecular Weight395.44 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ezetimibe Impurity N38 CAS 1510820-22-0 chemical structure

Description

The occurrence of Ezetimibe Impurity N38 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Ezetimibe Impurity N38 (CAS 1510820-22-0), a pharmacopoeial impurity reference standard (molecular formula C24H23F2NO2, MW 395.44 g/mol) used for the identification and quantification of trace impurities in APIs.

Ezetimibe Impurity N38 (C24H23F2NO2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.

CATO manufactures Ezetimibe Impurity N38 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC24H23F2NO2
Molecular Weight395.44 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)13.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1992
Halogen ContentF-containing
Nitrogen Atoms1

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