PHR1710

Cetirizine hydrochloride Related Compound A

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Cetirizine ethyl ester dihydrochloride, (RS)-2-[2-[4-[(4-chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic acid ethyl ester dihydrochloride (Cetirizine hydrochloride Related Compound A), (RS)-2-[2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic acid ethyl ester dihydrochloride
• Empirical Formula (Hill Notation): C₂₃H₂₉ClN₂O₃ · 2HCl
• CAS Number: 246870-46-2
• Molecular Weight: 489.86
• EC Number: 206-137-4
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to USP 1102930
• API family: cetirizine
• 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
• InChI: 1S/C23H29ClN2O3/c1-2-29-22(27)18-28-17-16-25-12-14-26(15-13-25)23(19-6-4-3-5-7-19)20-8-10-21(24)11-9-20/h3-11,23H,2,12-18H2,1H3
• InChI key: ASHQTVRYHSZGQY-UHFFFAOYSA-N

Description

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.

Safety Information

• Pictograms: GHS07,GHS09
• Signal Word: Warning
• Hazard Statements: H302,H410
• Precautionary Statements: P264 - P270 - P273 - P301 + P312 - P391 - P501
• Hazard Classifications: Acute Tox. 4 Oral - Aquatic Acute 1 - Aquatic Chronic 1
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable