Cetirizine EP Impurity G CAS 109806-71-5

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.109806-71-5
Molecular FormulaC19H23ClN2O
Molecular Weight330.85 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Cetirizine EP Impurity G CAS 109806-71-5 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Cetirizine EP Impurity G.

CATO supplies Cetirizine EP Impurity G (CAS 109806-71-5), a pharmacopoeial impurity reference standard (molecular formula C19H23ClN2O, MW 330.85 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Cetirizine EP Impurity G is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 330.85 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

As a certified reference material (CRM), Cetirizine EP Impurity G meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC19H23ClN2O
Molecular Weight330.85 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>90%
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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1988
Halogen ContentCl-containing
Nitrogen Atoms2

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