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PHR1710

Supelco

Cetirizine hydrochloride Related Compound A

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
(RS)-2-[2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic acid ethyl ester dihydrochloride, (RS)-2-[2-[4-[(4-chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic acid ethyl ester dihydrochloride (Cetirizine hydrochloride Related Compound A), Cetirizine ethyl ester dihydrochloride
Empirical Formula (Hill Notation):
C23H29ClN2O3 · 2HCl
CAS Number:
Molecular Weight:
489.86
EC Number:
NACRES:
NA.24

Quality Level

grade

certified reference material
pharmaceutical secondary standard

CofA

current certificate can be downloaded

packaging

pkg of 40 mg

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

-10 to -25°C

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General description

Cetirizine hydrochloride Related Compound A is an impurity of cetirizine hydrochloride. Cetirizine hydrochloride is a second-generation antihistamine compound. It is a major metabolite of hydroxyzine that exhibits high specific affinity for histamine H1 receptor. It is used for the management of allergies, hay fever, angioedema, and urticaria.
Pharmaceutical secondary standard for application in quality control. Provides pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Application

Cetirizine hydrochloride has been used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by spectrophotometry and 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.

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 LRAA7298 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Signal Word

Danger

Hazard Classifications

Eye Dam. 1 - Repr. 2 - Skin Irrit. 2 - Skin Sens. 1

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

Development and Validation of RP-HPLC Method for Simultaneous Estimation of Cetirizine Hydrochloride and Phenylpropanolamine Hydrochloride in Tablet Dosage Form.
Dhongle PS, et al.
Research Journal of Pharmacy and Technology, 4(9), 1471-1474 (2011)
Simultaneous quantitation and validation of paracetamol, phenylpropanolamine hydrochloride and cetirizine hydrochloride by RP-HPLC in bulk drug and formulation
Suryan AL, et al.
International Journal of Pharmaceutical Sciences and Drug Research, 3(4), 303-308 (2011)
Determination and quantification of cetirizine HCl in dosage formulations by RP-HPLC
Wankhede SB, et al.
International Journal of Pharmaceutical Sciences and Drug Research, 4(3), 222-226 (2012)
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)

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