Description

Cetirizine 3-Chloro Impurity (CAS NO 1232460-31-9) is a high-purity chemical reference standard critical for ensuring the quality and safety of the active pharmaceutical ingredient cetirizine. This compound is essential for analytical method development, validation, and regulatory compliance in pharmaceutical manufacturing. It is primarily required by quality control laboratories, research institutions, and API producers focused on antihistamine development and production.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of the 3-chloro derivative in cetirizine drug substance and finished products.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, and GC methods to monitor impurity profiles in compliance with ICH Q3A and Q3B guidelines.
• Quality Control & Assurance: Employed in routine batch testing of cetirizine to ensure it meets stringent pharmacopeial specifications (USP, EP, BP).
• Stability Studies: Used to track the formation of this specific degradation impurity under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to health authorities like the FDA and EMA.
• Research & Development: Serves as a key intermediate or marker in synthetic pathway studies and process chemistry optimization for cetirizine.

Basic Information

Item	Details
Product Name	Cetirizine 3-Chloro Impurity
CAS No.	1232460-31-9
Molecular Formula	C21H25ClN2O3 • 2HCl
Molecular Weight	461.81 g/mol
Synonyms	3-Chloro Cetirizine Impurity; Cetirizine Chloro Impurity; 2-[2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic acid dihydrochloride; (RS)-2-[2-[4-[(4-Chloro-α-phenylbenzyl)piperazin-1-yl]ethoxy]acetic acid dihydrochloride; Cetirizine Related Compound C (Chloro); Zyrtec 3-Chloro Impurity
EINECS	Contact for details

Quality Control

Every batch of Cetirizine 3-Chloro Impurity is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the exacting standards of pharmaceutical reference material users. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters, supporting compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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