Cetirizine EP Impurity G (2HCl salt)
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164726-80-1Cetirizine EP Impurity G (2HCl salt)

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Catalogue No.:VL330007
CAS No.:164726-80-1
Mol. Formula:C19H23ClN2O.2HCl
Mol. Weight:403.77 g/mol

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100 mg $129.00
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Additional information on CAS 164726-80-1

Parent drug

Cetirizine

IUPAC Name

(RS)-2-[4-[(4-chlorophenyl)phenylmethyl]piperazin-1- yl]ethan-1-ol dihydrochloride

Pharmacopeial Synonyms

Cetirizine Related Compound G; Cetirizine Ethanol

Synonyms

4-[(4-Chlorophenyl)phenylmethyl]-1-piperazineethanol dihydrochloride; 4-(p-Chloro-a-phenylbenzyl)-1-piperazineethanol Dihydrochloride ;Norchlorcyclizine

Smiles

O=C(O)COCCN1CCN(C(C2=CC=CC=C2Cl)C3=CC=CC=C3)CC1.[H]Cl.[H]Cl

InChI

InChI=1S/C21H25ClN2O3.2ClH/c22-19-9-5-4-8-18(19)21(17-6-2-1-3-7-17)24-12-10-23(11-13-24)14-15-27-16-20(25)26;;/h1-9,21H,10-16H2,(H,25,26);2*1H

Shipping Condition

Ambient Temperature

Description

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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