Description

Cetirizine 3-Chloro Impurity Dihydrochloride is a high-purity reference standard and pharmaceutical intermediate critical for quality control and research in antihistamine development. This compound is essential for the accurate identification, quantification, and control of process-related impurities during the synthesis of Cetirizine hydrochloride, ensuring final drug product safety and efficacy. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on API development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for HPLC, LC-MS, and other analytical methods in quality control laboratories.
• API Development & Validation: Critical for method development and validation studies to monitor and control synthetic impurities in Cetirizine hydrochloride production.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files.
• Research & Degradation Studies: Employed in forced degradation and stability studies to understand the degradation pathways of Cetirizine.
• Chemical Synthesis Intermediate: Serves as a building block or intermediate in advanced organic synthesis and process chemistry research.

Basic Information

Product Name	Cetirizine 3-Chloro Impurity Dihydrochloride
CAS No.	1232460-29-5
Molecular Formula	C21H27Cl3N2O3 • 2HCl
Molecular Weight	538.29 g/mol (for dihydrochloride salt)
Synonyms	3-Chloro Cetirizine Dihydrochloride; 2-[2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic acid, 3-chloro derivative dihydrochloride; Cetirizine Chloro Impurity Dihydrochloride; Cetirizine Related Compound Dihydrochloride; (RS)-2-[2-[4-[(4-Chloro-α-phenylbenzyl)piperazin-1-yl]ethoxy]acetic acid dihydrochloride; Zyrtec 3-Chloro Impurity Dihydrochloride
EINECS	Contact for details

Quality Control

Our Cetirizine 3-Chloro Impurity Dihydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for pharmaceutical impurity standards. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every shipment.

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 must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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