Azelastine impurity 53 CAS CATO-C4X-139653

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-139653
Molecular FormulaC14H26N2O2
Molecular Weight254.37 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Azelastine impurity 53 CAS CATO-C4X-139653 chemical structure

Description

CATO manufactures Azelastine impurity 53 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.

Azelastine impurity 53 (CAS CATO-C4X-139653) is a certified pharmaceutical impurity reference standard with the molecular formula C14H26N2O2 and a molecular weight of 254.37 g/mol.

Based on its molecular formula C14H26N2O2, Azelastine impurity 53 contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 254.37 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.

Physical & Chemical Properties

Molecular FormulaC14H26N2O2
Molecular Weight254.37 g/mol
AppearanceWhite to pale yellow crystalline powder
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
Nitrogen Atoms2

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