Azelastine Impurity 19 CAS 50492-22-3

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.50492-22-3
Molecular FormulaC6H11NO
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Azelastine Impurity 19 CAS 50492-22-3 chemical structure

Description

Azelastine Impurity 19 (CAS 50492-22-3) is a certified pharmaceutical impurity reference standard with the molecular formula C6H11NOHCl and a molecular weight of 149.62 g/mol.

Based on its molecular formula C6H11NOHCl, Azelastine Impurity 19 contains an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 149.62 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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.

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.

Physical & Chemical Properties

Molecular FormulaC6H11NO HCl
Molecular Weight149.62 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)1.0
CAS Registry Year (est.)1971
Halogen ContentCl-containing
Nitrogen Atoms1

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