Description

Rac Cetirizine-D8 n-Oxide CAS NO 1216444-13-1 is a high-purity, deuterated 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 metabolic studies. It is an essential tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory testing facilities requiring precise measurement of cetirizine and its metabolites.

Application

• Quantitative Bioanalysis: Serves as a stable isotope-labeled internal standard for the accurate LC-MS/MS quantification of cetirizine and its metabolites in biological matrices (plasma, serum, urine).
• Pharmacokinetic (PK) Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) for cetirizine in clinical and pre-clinical trials.
• Metabolite Profiling & Identification: Aids in the structural elucidation and quantification of oxidative metabolites of cetirizine during drug metabolism studies.
• Method Development & Validation: Used as a reference material to develop, optimize, and validate robust analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Quality Control in Manufacturing: Supports impurity profiling and stability testing of cetirizine active pharmaceutical ingredient (API) and finished drug products.
• Forensic & Doping Control Analysis: Provides a reliable standard for the confirmatory analysis of cetirizine in forensic toxicology and anti-doping programs.

Basic Information

Item	Detail
Product Name	Rac Cetirizine-D8 n-Oxide
CAS No.	1216444-13-1
Molecular Formula	C21H17D8ClN2O3
Molecular Weight	Approx. 397.93 g/mol
Synonyms	Cetirizine-d8 N-Oxide; [2-[4-[(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic Acid-d8 N-Oxide; (±)-Cetirizine-d8 N-Oxide; Zyrtec-d8 N-Oxide; UCB-P071-d8 N-Oxide; 2-[2-[4-[(4-Chloro-α-phenylbenzyl)piperazin-1-yl]ethoxy]acetic Acid-d8 N-Oxide
EINECS	Contact for details

Quality Control

Every batch of Rac Cetirizine-D8 n-Oxide is manufactured under strict quality management systems and undergoes comprehensive analytical characterization. We guarantee high chemical and isotopic purity verified by NMR (¹H, ¹³C), high-resolution mass spectrometry (HRMS), and HPLC. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting purity, isotopic enrichment, and solvent content to support your regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry environment. This material is hygroscopic (moisture-sensitive). Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (NMR)	Conforms to structure
Identification (HRMS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
Chemical Purity (NMR)	≥ 98.0%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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