Azelastine Impurity 20 CAS 47491-38-3

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.47491-38-3
Molecular FormulaC21H22ClN3O
Molecular Weight367.87 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Azelastine Impurity 20 CAS 47491-38-3 chemical structure

Description

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Azelastine Impurity 20 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 367.87 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

Azelastine Impurity 20 (CAS 47491-38-3) is a certified pharmaceutical impurity reference standard with the molecular formula C21H22ClN3O and a molecular weight of 367.87 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.

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 FormulaC21H22ClN3O
Molecular Weight367.87 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1970
Halogen ContentCl-containing
Nitrogen Atoms3

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