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PHR1607

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Hydroxyzine Dihydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Hydroxyzine dihydrochloride

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About This Item

Empirical Formula (Hill Notation):
C21H27ClN2O2 · 2HCl
CAS Number:
Molecular Weight:
447.83
EC Number:
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

agency

traceable to BP 841
traceable to Ph. Eur. H1435000
traceable to USP 1333003

API family

hydroxyzine

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

SMILES string

Cl[H].Cl[H].OCCOCCN1CCN(CC1)C(c2ccccc2)c3ccc(Cl)cc3

InChI

1S/C21H27ClN2O2.2ClH/c22-20-8-6-19(7-9-20)21(18-4-2-1-3-5-18)24-12-10-23(11-13-24)14-16-26-17-15-25;;/h1-9,21,25H,10-17H2;2*1H

InChI key

ANOMHKZSQFYSBR-UHFFFAOYSA-N

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.

Application

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.
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.

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.

Footnote

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.

pictograms

Health hazardExclamation mark

signalword

Warning

Hazard Classifications

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

target_organs

Central nervous system

wgk_germany

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable


Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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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)
Optimized and validated spectrophotometric methods for the determination of hydroxyzine hydrochloride in pharmaceuticals and urine using iodine and picric acid
Rajendraprasad N, et al
J. Serb. Chem. Soc., 76(11), 1551-1560 (2011)
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)
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)
Diphenylmethane antihistaminics
Drugs and Poisons in Humans: A Handbook of Practical Analysis, 315-324 (2005)

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