Ezetimibe Impurity 59 CAS CATO-C4X-109859

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-109859
Molecular FormulaC23H19F2NO3
Molecular Weight395.40 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ezetimibe Impurity 59 CAS CATO-C4X-109859 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 59.

Ezetimibe Impurity 59 (CAS CATO-C4X-109859) is a certified pharmaceutical impurity reference standard with the molecular formula C23H19F2NO3 and a molecular weight of 395.40 g/mol.

Structurally, Ezetimibe Impurity 59 (C23H19F2NO3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 14.0, corresponding to approximately 14 ring(s) or double-bond equivalent(s). With a molecular weight of 395.40 g/mol, it falls into the moderately-high-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 FormulaC23H19F2NO3
Molecular Weight395.40 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore at 2-8°C, 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
Halogen ContentF-containing
Nitrogen Atoms1

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