Cetirizine Impurity 27 CAS CATO-C4X-158227

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-158227
Molecular FormulaC19H23ClN2O
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Cetirizine Impurity 27 CAS CATO-C4X-158227 chemical structure

Description

The occurrence of Cetirizine Impurity 27 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Cetirizine Impurity 27 (CAS CATO-C4X-158227), a pharmacopoeial impurity reference standard (molecular formula C19H23ClN2OHCl, MW 367.31 g/mol) used for the identification and quantification of trace impurities in APIs.

Cetirizine Impurity 27 (C19H23ClN2OHCl) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; 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.

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 FormulaC19H23ClN2O 2*HCl
Molecular Weight367.31 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
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)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms2

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