Ezetimibe Impurity 52 CAS 90319-52-1

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.90319-52-1
Molecular FormulaC9H9NO2
Molecular Weight163.17 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ezetimibe Impurity 52 CAS 90319-52-1 chemical structure

Description

As a process- or degradation-related impurity, Ezetimibe Impurity 52 (CAS 90319-52-1, C9H9NO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Ezetimibe Impurity 52 (C9H9NO2) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. 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).

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.

As a certified reference material (CRM), Ezetimibe Impurity 52 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC9H9NO2
Molecular Weight163.17 g/mol
AppearanceOff-white to pale yellow crystalline powder. (faint amine-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1982
Nitrogen Atoms1

Related Ezetimibe Standards

Recommended Standards

Why CATO?