Description

Etoricoxib Impurity 41 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) 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: Serves as a certified impurity standard for the identification and quantification of related substances in Etoricoxib API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to confirm that Etoricoxib products meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Regulatory Compliance & Documentation: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research on Degradation Pathways: Aids in understanding the chemical stability and degradation mechanisms of Etoricoxib during synthesis and storage.

Basic Information

Product Name	Etoricoxib Impurity 41
CAS No.	855307-80-1
Molecular Formula	C18H15ClN2O2S
Molecular Weight	358.84 g/mol
Synonyms	5-Chloro-2-(6-methylpyridin-3-yl)-3-(4-methylsulfonylphenyl)pyridine; Etoricoxib Related Compound 41; Etoricoxib Impurity C; 3-(4-Methanesulfonylphenyl)-5-chloro-2-(6-methylpyridin-3-yl)pyridine; 5-Chloro-3-(4-(methylsulfonyl)phenyl)-2-(6-methylpyridin-3-yl)pyridine; Etoricoxib EP Impurity C; Etoricoxib USP Impurity C
EINECS	Contact for details

Quality Control

Our Etoricoxib Impurity 41 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (IR, NMR, MS), to ensure it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white 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%
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.