Azelastine EP Impurity B CAS 110406-94-5

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.110406-94-5
Molecular FormulaC14H21N3O
Molecular Weight247.34 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Azelastine EP Impurity B CAS 110406-94-5 chemical structure

Description

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 supplies Azelastine EP Impurity B (CAS 110406-94-5), a pharmacopoeial impurity reference standard (molecular formula C14H21N3O, MW 247.34 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C14H21N3O, Azelastine EP Impurity B contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 247.34 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

As a certified reference material (CRM), Azelastine EP Impurity B 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 FormulaC14H21N3O
Molecular Weight247.34 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1988
Nitrogen Atoms3

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