Vilanterol Impurity 33 CAS CATO-C4X-193533

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-193533
Molecular FormulaC16H23BrCl2O2
Molecular Weight398.16 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Vilanterol Impurity 33 CAS CATO-C4X-193533 chemical structure

Description

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.

As a process- or degradation-related impurity, Vilanterol Impurity 33 (CAS CATO-C4X-193533, C16H23BrCl2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Vilanterol Impurity 33 (C16H23BrCl2O2) contains a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine/bromine substitution, an aromatic ring system. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 FormulaC16H23BrCl2O2
Molecular Weight398.16 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
StorageStore at room temperature
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl/Br-containing

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