Description

Cetirizine Ethyl Ester (USP RC A) is a key pharmaceutical intermediate, specifically the ethyl ester derivative of the active pharmaceutical ingredient cetirizine. This high-purity compound is critical for ensuring the quality, efficacy, and regulatory compliance of the final antihistamine drug product. It is primarily required by manufacturers in the pharmaceutical and fine chemical industries for the synthesis and quality control of cetirizine hydrochloride and related medications.

Application

• Pharmaceutical Intermediate: Primary use in the synthesis of Cetirizine Hydrochloride, a widely used second-generation antihistamine.
• Reference Standard (USP RC A): Serves as a United States Pharmacopeia (USP) Reference Standard for analytical testing, method validation, and quality control in API and finished dosage form manufacturing.
• Process Development & Research: Utilized in research and development (R&D) for optimizing synthetic routes and scaling up production processes.
• Analytical Chemistry: Employed as a high-purity standard in HPLC, GC, and other chromatographic methods for assay and impurity profiling.
• Regulatory Compliance: Essential for conducting stability studies, batch release testing, and ensuring compliance with FDA, ICH, and other global regulatory guidelines.

Basic Information

Product Name	Cetirizine Ethyl Ester (USP RC A)
CAS No.	246870-46-2
Molecular Formula	C21H25ClN2O3
Molecular Weight	388.89 g/mol
Synonyms	2-[2-[4-[(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]ethyl acetate; Ethyl 2-[2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetate; (±)-Cetirizine Ethyl Ester; Cetirizine Ethyl Ester Impurity; Cetirizine Related Compound A; USP Cetirizine Related Compound A RS
EINECS	Contact for details

Quality Control

As a USP Reference Standard grade material, this product is manufactured and tested to meet the exacting specifications of the United States Pharmacopeia. Our quality assurance includes rigorous identity, purity, and impurity profile testing via advanced analytical techniques. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing compliance with USP monograph requirements and supporting cGMP standards for pharmaceutical use.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with USP/ICH limits
Loss on Drying	≤ 1.0%

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