Azelastine Impurity 68 CAS CATO-C4X-139668

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-139668
Molecular FormulaC15H13ClN2O
Molecular Weight272.73 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Azelastine Impurity 68 CAS CATO-C4X-139668 chemical structure

Description

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.

Azelastine Impurity 68 (CAS CATO-C4X-139668) is a certified pharmaceutical impurity reference standard with the molecular formula C15H13ClN2O and a molecular weight of 272.73 g/mol.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Azelastine Impurity 68 is typically pale yellow to yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 272.73 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

Physical & Chemical Properties

Molecular FormulaC15H13ClN2O
Molecular Weight272.73 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms2

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