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Cetirizine Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

[2-[4-[(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic acid dihydrochloride, CTZ, CET, Cetirizine dihydrochloride, 2-[4-(4-Chlorobenzhydryl) piperazine-1-yl]ethoxyacetic acid dihydrochloride, CE
Empirical Formula (Hill Notation):
C21H25ClN2O3 · 2HCl
CAS Number:
Molecular Weight:
MDL number:
PubChem Substance ID:

Quality Level


certified reference material
pharmaceutical secondary standard


current certificate can be downloaded


pkg of 1 g


HPLC: suitable
gas chromatography (GC): suitable


pharmaceutical (small molecule)



pharmacopeia traceability

traceable to BP 837
traceable to PhEur C0980650
traceable to USP 1102929

storage temp.


SMILES string




InChI key


Gene Information

human ... HRH1(3269)

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General description

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Cetirizine hydrochloride, a second generation antihistaminic drug, is one of the carboxylated metabolites of hydroxyzine that can typically bind to histamine H1 receptor. It is effective against diseases such as urticaria, angioedema, allergies and hay fever.


Cetirizine Hydrochloride may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by various chromatography techniques.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Biochem/physiol Actions

Cetirizine hydrochloride is an orally active and selective H1-receptor antagonist. Antihistaminic; Piperazines. Non-sedating type histamine H1-receptor antagonist; major metabolite of hydroxyzine. Pharmacological activity resides primarily in the (R)-isomer.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.


To see an example of a Certificate of Analysis for this material enter LRAA5757 in the slot below. This is an example certificate only and may not be the lot that you receive.


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Signal Word


Hazard Statements

Hazard Classifications

Acute Tox. 4 Oral

Storage Class Code

13 - Non Combustible Solids



Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

Development and validation of stability indicating assay method of cetirizine hydrochloride by HPLC.
Khan MI, et al.
African Journal of Pharmacy and Pharmacology, 5(2), 143-149 (2011)
A rapid, stability indicating RP-UPLC method for simultaneous determination of ambroxol hydrochloride, cetirizine hydrochloride and antimicrobial preservatives in liquid pharmaceutical formulation.
Trivedi RK, et al.
Scientia Pharmaceutica, 79(3), 525-544 (2011)
Determination and quantification of cetirizine HCl in dosage formulations by RP-HPLC.
ARAYNE MS, et al.
Science, 1(4), 1-4 (2005)
RP-HPLC and spectrophotometric estimation of ambroxol hydrochloride and cetirizine hydrochloride in combined dosage form.
Bhatia NM, et al.
Indian Journal of Pharmaceutical Sciences, 70(5), 603-603 (2008)
Development and validation of a novel RP-HPLC method for simultaneous determination of paracetamol, phenylephrine hydrochloride, caffeine, cetirizine and nimesulide in tablet formulation.
Dewani AP, et al.
Arabian Journal of Chemistry, 8(4), 591-598 (2015)

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