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Hydroxyzine Dihydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Hydroxyzine dihydrochloride
Empirical Formula (Hill Notation):
C21H27ClN2O2 · 2HCl
CAS Number:
Molecular Weight:
EC Number:
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 841
traceable to PhEur H1435000
traceable to USP 1333003

storage temp.


SMILES string




InChI key


Gene Information

human ... HRH1(3269)

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General description

Hydroxyzine dihydrochloride is an antihistaminic drug and a member of the diphenylmethanes family. It exerts its action by blocking the action of histamine, a substance in the body that causes allergic symptoms.
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.


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.
Hydroxyzine dihydrochloride may be used as a pharmaceutical reference standard for the determination of the analyte in bulk drug and pharmaceutical formulations by spectrophotometry and high performance liquid chromatography.

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 LRAA4723 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.


Exclamation markHealth hazard

Signal Word


Hazard Statements

Hazard Classifications

Acute Tox. 4 Oral - Repr. 2 - STOT SE 3

Target Organs

Central nervous system

Storage Class Code

11 - Combustible Solids



Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

Sensitive and selective extractive spectrophotometric method for the determination of hydroxyzine dihydrochloride in pharmaceuticals
Rajendraprasad N, et al.
Journal of the Mexican Chemical Society, 54(4), 233-239 (2010)
A High performance liquid chromatography method for determination of hydroxyzine hydrochloride in syrup
Brand MA, et al.
Latin American Journal of Pharmacy, 30(9), 1798-1802 (2011)
Diphenylmethane antihistaminics
Drugs and Poisons in Humans: A Handbook of Practical Analysis, 315-324 (2005)
New method development for hydroxyzine determination: application in stability studies, pharmaceutical formulations, and humane serum
Sher N, et al.
Journal of Liquid Chromatography and Related Technologies, 38(8), 911-918 (2015)
Green approach towards the determination of hydroxyzine dihydrochloride in pure and pharmaceutical dosage forms.
Mumtaz A, et al.
Pakistan Journal of Pharmaceutical Sciences, 27(5), 911-918 (2014)

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