Description

Cetirizine Ep Impurity E is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Cetirizine. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying this specific impurity. It is essential for research and development, method validation, and stability studies within the global pharmaceutical and fine chemical industries.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of Cetirizine Ep Impurity E in Cetirizine API and finished drug products.
• Critical component in analytical method development and validation (e.g., HPLC, UPLC, LC-MS) for impurity profiling.
• Essential for pharmaceutical quality control (QC) and quality assurance (QA) laboratories to meet ICH, USP, and EP guidelines.
• Used in stability studies to monitor impurity formation under various stress conditions.
• Valuable for regulatory submissions (e.g., ANDA, NDA) to demonstrate thorough impurity characterization.
• Supports research and development of Cetirizine synthesis processes to understand and minimize impurity formation.

Basic Information

Product Name	Cetirizine Ep Impurity E
CAS No.	1841445-61-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cetirizine Related Compound E; Cetirizine Impurity E; 2-[2-[4-[(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic Acid Impurity E; (RS)-[2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic Acid Impurity E; Cetirizine EP Impurity E; Cetirizine USP Impurity E; Cetirizine Process Impurity E
EINECS	Contact for details

Quality Control

Every batch of Cetirizine Ep Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles is provided with each shipment and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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
Water Content (KF)	≤ 1.0%

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