Ezetimibe Impurity 126 CAS 1376615-01-8

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.1376615-01-8
Molecular FormulaC24H19FINO3
Molecular Weight515.32 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ezetimibe Impurity 126 CAS 1376615-01-8 chemical structure

Description

The occurrence of Ezetimibe Impurity 126 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/iodine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Ezetimibe Impurity 126 (CAS 1376615-01-8, C24H19FINO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Ezetimibe Impurity 126 (C24H19FINO3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/iodine 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 presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

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 FormulaC24H19FINO3
Molecular Weight515.32 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)15.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1991
Halogen ContentF/I-containing
Nitrogen Atoms1

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