Description

Cetirizine Ep Impurity B(Base) is a high-purity reference standard and pharmaceutical intermediate, specifically identified as an impurity of the antihistamine drug Cetirizine. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring drug safety and regulatory compliance. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and manufacturers of active pharmaceutical ingredients (APIs) for impurity profiling and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Cetirizine drug substances and finished products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels during API synthesis and formulation.
• Quality Control & Assurance: Serves as a system suitability standard in QC labs to ensure analytical procedures are performing correctly for impurity detection.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to 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 testing of Cetirizine to understand impurity formation pathways.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Cetirizine.

Basic Information

Product Name	Cetirizine Ep Impurity B(Base)
CAS No.	942193-17-1
Molecular Formula	C21H25ClN2O3
Molecular Weight	388.89 g/mol
Synonyms	Cetirizine Impurity B; Cetirizine Related Compound B; 2-[2-[4-[(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic Acid Impurity B; (RS)-2-(2-(4-((4-Chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)acetic Acid Impurity; EP Impurity B of Cetirizine; USP Cetirizine Related Compound B; (4-Chlorophenyl)(phenyl)methyl Piperazine Derivative
EINECS	Contact for details

Quality Control

Our Cetirizine Ep Impurity B(Base) is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and control of specified impurities, to ensure it meets the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards. The quality system is designed to support compliance with cGMP, ICH Q3A/B guidelines, and relevant pharmacopeial standards (USP, EP).

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual 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.