Description

Etoricoxib Impurity 10 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 by accurately identifying and quantifying this specific impurity. It is essential for research and development, method validation, and routine batch testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Etoricoxib Impurity 10 in API and finished drug products.
• Analytical Method Development & Validation: Crucial for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions (e.g., heat, humidity, light).
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Etoricoxib.

Basic Information

Product Name	Etoricoxib Impurity 10
CAS No.	316149-01-6
Molecular Formula	C18H15ClN2O2S
Molecular Weight	358.84 g/mol
Synonyms	5-Chloro-2-(6-methylpyridin-3-yl)-3-(4-methylsulfonylphenyl)pyridine; 5-Chloro-3-(4-(methylsulfonyl)phenyl)-2-(6-methylpyridin-3-yl)pyridine; Etoricoxib Related Compound; Etoricoxib Process Impurity; Arcoxia Impurity; COX-2 Inhibitor Impurity; 316149-01-6
EINECS	Contact for details

Quality Control

Every batch of Etoricoxib Impurity 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each 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 solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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