Cetirizine EP Impurity A CAS 303-26-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.303-26-4
Molecular FormulaC17H19ClN2
Molecular Weight286.80 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Cetirizine EP Impurity A CAS 303-26-4 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 Cetirizine EP Impurity A (CAS 303-26-4), a pharmacopoeial impurity reference standard (molecular formula C17H19ClN2, MW 286.80 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Cetirizine EP Impurity A (C17H19ClN2) is characterized by a nitrogen-containing heterocyclic scaffold, a nitrile group, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

CATO manufactures Cetirizine EP Impurity A under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC17H19ClN2
Molecular Weight286.80 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1957
Halogen ContentCl-containing
Nitrogen Atoms2

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