Ezetimibe Impurity 17(SCH59566) CAS 1296129-15-1

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1296129-15-1
Molecular FormulaC24H21F2NO3
Molecular Weight409.43 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ezetimibe Impurity 17(SCH59566) CAS 1296129-15-1 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Ezetimibe Impurity 17(SCH59566).

Ezetimibe Impurity 17(SCH59566) (CAS 1296129-15-1) is a certified pharmaceutical impurity reference standard with the molecular formula C24H21F2NO3 and a molecular weight of 409.43 g/mol.

Ezetimibe Impurity 17(SCH59566) (C24H21F2NO3) 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. 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.

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 FormulaC24H21F2NO3
Molecular Weight409.43 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
StorageStore at room temperature, protect from light, keep sealed and dry
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.)1990
Halogen ContentF-containing
Nitrogen Atoms1

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