Description

Cetirizine Impurity (4-Chlorobenzophenone) CAS NO 2724877-99-8 is a high-purity reference standard and synthetic intermediate critical for pharmaceutical quality control and research. This compound is essential for the accurate identification, quantification, and monitoring of process-related impurities in the manufacturing of the widely used antihistamine, Cetirizine. It serves as a vital tool for analytical chemists, quality assurance professionals, and R&D scientists working in pharmaceutical development and regulatory compliance. Ensuring the integrity of this impurity standard is fundamental to guaranteeing drug safety, efficacy, and adherence to stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of 4-Chlorobenzophenone in Cetirizine drug substance and finished products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and GC analytical methods in quality control laboratories.
• Impurity Profiling & Control: Used to establish impurity thresholds, study degradation pathways, and ensure compliance with ICH Q3A/B guidelines on impurities in new drug substances and products.
• Process Chemistry Research: Employed as a key intermediate or marker in studying and optimizing the synthetic route of Cetirizine hydrochloride.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Used as a benchmark to monitor the formation of specific impurities during forced degradation and long-term stability testing of Cetirizine formulations.

Basic Information

Product Name	Cetirizine Impurity (4-Chlorobenzophenone)
CAS No.	2724877-99-8
Molecular Formula	C13H9ClO
Molecular Weight	216.66 g/mol
Synonyms	4-Chlorobenzophenone; (4-Chlorophenyl)(phenyl)methanone; p-Chlorobenzophenone; Benzophenone, 4-chloro-; Cetirizine Related Compound; Cetirizine Impurity B (as per some references); 4-Chlorodiphenyl ketone; 4'-Chlorobenzophenone
EINECS	Contact for details

Quality Control

Our Cetirizine Impurity (4-Chlorobenzophenone) is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical analysis. Each batch is subjected to comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results and methods. Our quality commitment aligns with the principles of GMP and ICH guidelines, supporting your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Keep the container sealed to prevent moisture absorption and contamination.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5% w/w

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