Description

Cetirizine Ep Impurity B Ethyl Ester is a high-purity reference standard and synthetic intermediate critical for pharmaceutical research and development. This compound is essential for the analytical characterization, method validation, and quality control of the widely used antihistamine drug, Cetirizine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in impurity profiling, stability studies, and regulatory compliance for drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for HPLC, LC-MS, and other chromatographic methods to quantify and qualify related substances in Cetirizine API and finished dosage forms.
• Method Development and Validation: Critical for developing and validating analytical procedures as per ICH Q2(R1) guidelines to ensure specificity, accuracy, and precision in impurity detection.
• Regulatory Compliance and Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed in forced degradation and long-term stability studies to identify and monitor degradation pathways of Cetirizine under various stress conditions.
• Process Chemistry Research: Serves as a key intermediate or marker in the research and optimization of synthetic routes for Cetirizine hydrochloride, aiding in impurity genesis and control.
• Quality Control (QC) Testing: Integral to in-process control and release testing within GMP manufacturing facilities to ensure the final API meets stringent purity specifications.

Basic Information

Product Name	Cetirizine Ep Impurity B Ethyl Ester
CAS No.	19178-83-7
Molecular Formula	C21H25ClN2O3
Molecular Weight	388.89 g/mol
Synonyms	2-[2-[4-[(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic Acid Ethyl Ester; Ethyl 2-[2-[4-[(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetate; Cetirizine Ethyl Ester Impurity; Cetirizine Related Compound B Ethyl Ester; (RS)-2-[2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic Acid Ethyl Ester; Zyrtec Impurity B Ethyl Ester; Cetirizine EP Impurity B (Ethyl Ester)
EINECS	Contact for details

Quality Control

Our Cetirizine Ep Impurity B Ethyl Ester is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis, to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment to support your quality and regulatory requirements.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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