Description

Cetirizine Impurity 28 is a high-purity chemical reference standard used in the analysis and quality control of the active pharmaceutical ingredient (API) Cetirizine. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure the safety, efficacy, and regulatory compliance of antihistamine drug products. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance (QA), and quality control (QC) for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Cetirizine API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in accordance with ICH guidelines.
• Quality Control & Batch Release: Employed in routine QC testing to monitor impurity profiles and ensure batches meet pharmacopeial specifications (e.g., USP, EP, BP).
• Stability Studies: Used to track the formation of degradation products in Cetirizine under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing impurity characterization data.
• Research & Development: Aids in the study of degradation pathways and the synthesis of high-purity Cetirizine.

Basic Information

Item	Details
Product Name	Cetirizine Impurity 28
CAS No.	1092460-01-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cetirizine Related Compound 28; Cetirizine EP Impurity I; Cetirizine USP Impurity; 2-[2-[4-[(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic Acid Impurity; (RS)-[2-[4-[(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic Acid Impurity 28
EINECS	Contact for details

Quality Control

Every batch of Cetirizine Impurity 28 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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