Description

Etoricoxib Impurity 29 is a designated reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient Etoricoxib. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for COX-2 inhibitor drugs.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Etoricoxib API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing to meet pharmacopeial (USP, EP) and ICH guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data on impurity characterization for regulatory filings with agencies like the FDA and EMA.
• Process Chemistry & Optimization: Helps in monitoring and controlling the formation of this impurity during the synthesis and purification stages of Etoricoxib manufacturing.

Basic Information

Product Name	Etoricoxib Impurity 29
CAS No.	646459-51-0
Molecular Formula	C18H15ClN2O2S
Molecular Weight	358.84 g/mol
Synonyms	5-Chloro-2-(6-chloropyridin-3-yl)-3-(4-methylsulfonylphenyl)pyridine; 5-Chloro-3-[4-(methylsulfonyl)phenyl]-2-(6-chloropyridin-3-yl)pyridine; Etoricoxib Chloro Impurity; Etoricoxib Related Compound 29; ARCOXIA Impurity 29; MK-0663 Impurity 29
EINECS	Contact for details

Quality Control

Our Etoricoxib Impurity 29 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for identity, purity, and related substances by validated methods such as HPLC and NMR. We support compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards for pharmaceutical impurities.

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 (moisture-sensitive) nature, the container should be kept in a desiccated environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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