Ezetimibe Impurity 78 CAS CATO-C4X-109878

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-109878
Molecular FormulaC30H39F2NO4Si2
Molecular Weight571.80 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ezetimibe Impurity 78 CAS CATO-C4X-109878 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 571.80 g/mol gives Ezetimibe Impurity 78 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Ezetimibe Impurity 78 (CAS CATO-C4X-109878) is a certified pharmaceutical impurity reference standard with the molecular formula C30H39F2NO4Si2 and a molecular weight of 571.80 g/mol.

The molecular framework of Ezetimibe Impurity 78 (C30H39F2NO4Si2) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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).

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 78 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 FormulaC30H39F2NO4Si2
Molecular Weight571.80 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 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)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms1

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