Azelastine impurity 56 CAS CATO-C4X-139656

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-139656
Molecular FormulaC10H17NO3
Molecular Weight199.25 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Azelastine impurity 56 CAS CATO-C4X-139656 chemical structure

Description

The molecular framework of Azelastine impurity 56 (C10H17NO3) is characterized by an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), 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).

Azelastine impurity 56 (CAS CATO-C4X-139656) is a certified pharmaceutical impurity reference standard with the molecular formula C10H17NO3 and a molecular weight of 199.25 g/mol.

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 Azelastine impurity 56 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 FormulaC10H17NO3
Molecular Weight199.25 g/mol
AppearanceWhite to pale yellow crystalline powder. (faint amine-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
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 Atoms1

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