Description

tert-Butyl Cetirizine-D8 is a high-purity, deuterium-labeled internal standard critical for advanced analytical chemistry. This compound is specifically designed for use in quantitative mass spectrometry, providing unmatched accuracy and reliability in pharmacokinetic and bioanalytical studies. It is an essential tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control units requiring precise measurement of cetirizine and its metabolites.

Application

• Internal Standard for LC-MS/MS: Primary application as a stable, isotopically labeled reference compound for the accurate quantification of cetirizine in complex biological matrices like plasma, serum, and urine.
• Pharmaceutical Research & Development: Enables precise drug metabolism and pharmacokinetics (DMPK) studies, bioavailability testing, and bioequivalence assessments for antihistamine formulations.
• Clinical Trial Analysis: Supports robust and GLP-compliant bioanalytical method development and validation for clinical phase studies involving cetirizine.
• Forensic and Toxicological Analysis: Used in specialized laboratories for the sensitive and specific detection of cetirizine in forensic toxicology cases.
• Method Development and Validation: Serves as a critical component in developing new, highly sensitive analytical methods for antihistamine detection and quantification.
• Quality Control in Manufacturing: Can be utilized in impurity profiling and stability-indicating assay methods for cetirizine active pharmaceutical ingredient (API) manufacturers.

Basic Information

Product Name	tert-Butyl Cetirizine-D8
CAS No.	1189466-71-4
Molecular Formula	C26H33D8ClN2O3
Molecular Weight	~465.1 g/mol
Synonyms	Cetirizine tert-butyl-D8; [²H₈]-tert-Butyl Cetirizine; 2-[2-[4-[(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic acid, 1,1-dimethylethyl ester-d8; Deutero tert-Butyl Cetirizine; Cetirizine-d8 tert-Butyl Ester; Deuterated tert-Butyl Cetirizine Internal Standard; (RS)-tert-Butyl 2-[2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetate-d8
EINECS	Contact for details

Quality Control

Our tert-Butyl Cetirizine-D8 is manufactured under strict quality control protocols to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is characterized by advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and mass spectrometry. A comprehensive Certificate of Analysis (COA) detailing purity, isotopic enrichment, and analytical data is provided with every shipment to support your regulatory and research documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98 atom % D
Chemical Purity (by NMR)	Conforms
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.