Description

Cetirizine-D8 (Hydrochloride) is a deuterated internal standard of the widely used antihistamine, cetirizine, specifically designed for analytical applications. This high-purity compound is essential for ensuring the accuracy and reliability of quantitative bioanalytical methods, such as LC-MS/MS, in pharmacokinetic and metabolism studies. It is a critical material for pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory bodies requiring precise drug quantification.

Application

• Internal Standard for Bioanalysis: Primary use as a stable, isotopically labeled internal standard for the accurate quantification of cetirizine in biological matrices (plasma, serum, urine) via LC-MS/MS.
• Pharmacokinetic (PK) Studies: Enables precise measurement of drug absorption, distribution, metabolism, and excretion (ADME) profiles in clinical and preclinical trials.
• Metabolite Identification & Profiling: Aids in distinguishing drug-derived metabolites from endogenous compounds in complex biological samples.
• Method Development & Validation: Serves as a key component in developing, optimizing, and validating robust analytical methods compliant with FDA, EMA, and ICH guidelines.
• Forensic & Doping Control Analysis: Used in forensic toxicology and anti-doping laboratories for the definitive identification and quantification of cetirizine.
• Quality Control in Manufacturing: Can be utilized as a reference standard for in-process control and final product release testing of cetirizine-based pharmaceuticals.

Basic Information

Product Name	Cetirizine-D8 (Hydrochloride)
CAS No.	2070015-04-0
Molecular Formula	C21H17D8ClN2O3•HCl
Molecular Weight	425.80 g/mol (approx.)
Synonyms	Cetirizine-d8 dihydrochloride; [²H₈]-Cetirizine hydrochloride; 2-[2-[4-[(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic acid-d8 dihydrochloride; (RS)-Cetirizine-d8 hydrochloride; Zyrtec-d8 hydrochloride; Deuterated Cetirizine HCl; Cetirizine (phenyl-d5, ethoxy-d3) hydrochloride
EINECS	Contact for details

Quality Control

Our Cetirizine-D8 (Hydrochloride) is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing parameters such as assay (by HPLC), isotopic enrichment (by MS), and impurity profile. We adhere to relevant industry standards for reference materials to support your compliance with GMP, GLP, and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to expected mass spectrum
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment	≥ 98 atom % D
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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