Azelastine impurity 66 CAS CATO-C4X-139666

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-139666
Molecular FormulaC23H26ClN3O
Molecular Weight395.93 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Azelastine impurity 66 CAS CATO-C4X-139666 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 Azelastine impurity 66.

Azelastine impurity 66 (CAS CATO-C4X-139666) is a certified pharmaceutical impurity reference standard with the molecular formula C23H26ClN3O and a molecular weight of 395.93 g/mol.

Azelastine impurity 66 (C23H26ClN3O) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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), Azelastine impurity 66 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 FormulaC23H26ClN3O
Molecular Weight395.93 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms3

Related Azelastine Standards

Recommended Standards

Why CATO?