Description

Cetirizine Ethyl Ester Dihydrochloride is a key pharmaceutical intermediate in the synthesis of the widely used antihistamine, Cetirizine. This high-purity compound is critical for ensuring the final drug product meets stringent pharmacopeial standards for purity, potency, and safety. It is an essential raw material for pharmaceutical manufacturers and research institutions engaged in the development and production of allergy and respiratory medications.

Application

• Primary Pharmaceutical Intermediate: The principal application is as a direct precursor in the multi-step synthesis of Cetirizine dihydrochloride, the active pharmaceutical ingredient (API) in prescription and over-the-counter allergy medications.
• Active Pharmaceutical Ingredient (API) Manufacturing: Serves as a critical building block in GMP-compliant production lines for bulk Cetirizine API, ensuring supply chain reliability for finished dosage formulators.
• Research & Development (R&D): Used in pharmaceutical R&D laboratories for process optimization, development of new synthetic routes, and scale-up studies for Cetirizine and its derivatives.
• Analytical Reference Standard: High-purity grades are utilized as a reference standard in quality control (QC) laboratories for method development, validation, and impurity profiling via HPLC and other chromatographic techniques.
• Generic Drug Production: A vital component for manufacturers producing bioequivalent generic versions of Cetirizine-based antihistamines, focusing on cost-effectiveness without compromising quality.

Basic Information

Product Name	Cetirizine Ethyl Ester Dihydrochloride
CAS No.	2732277-01-7
Molecular Formula	C21H27Cl2N2O3
Molecular Weight	441.36 g/mol
Synonyms	2-[2-[4-[(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic acid ethyl ester dihydrochloride; Ethyl 2-[2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetate dihydrochloride; Cetirizine Ethyl Ester HCl; Cetirizine Ethyl Ester 2HCl; [2-[4-[(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic Acid Ethyl Ester Dihydrochloride; Zyrtec Ethyl Ester Dihydrochloride (common trade name reference); Cetirizine Ester Dihydrochloride
EINECS	Contact for details

Quality Control

Our Cetirizine Ethyl Ester Dihydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for assay and impurity profile, to ensure it meets the high-purity standards required for pharmaceutical synthesis. Certificates of Analysis (COA) detailing all test results are provided and can be tailored to meet specific customer or regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.