Cetirizine EP Impurity G (Cetirizine Related Compound G; Cetirizine Ethanol Impurity), CAS 164726-80-1, is the 4-[(4-chlorophenyl)phenylmethyl]-1-piperazineethanol dihydrochloride impurity encountered during cetirizine manufacture. This polar dihydrochloride species can co-elute with target API in reversed phase HPLC and requires validated chromatographic methods and confirmed retention time, UV spectrum, and mass spectral identity for accurate quantification. Control strategies include targeted purification, solvent selection, and specification limits aligned with ICH Q3A/B thresholds. The impurity exhibits defined solubility and stability profiles under acidic conditions and must be monitored in stability studies and batch release testing to ensure compliance with pharmacopeial impurity criteria.
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