Description

Etoricoxib Impurity 9 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the drug substance Etoricoxib. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Etoricoxib Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or GC methods to monitor impurities during the manufacturing process.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of degradation products in Etoricoxib formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Etoricoxib.

Basic Information

Product Name	Etoricoxib Impurity 9
CAS No.	859824-65-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	5-Chloro-2-(6-methylpyridin-3-yl)-3-(4-(methylsulfonyl)phenyl)pyridine; Etoricoxib Related Compound 9; Etoricoxib Impurity C; Etoricoxib EP Impurity C; ARCOXIA Impurity 9; 5-Chloro-3-[4-(methylsulfonyl)phenyl]-2-(6-methyl-3-pyridinyl)pyridine
EINECS	Contact for details

Quality Control

Our Etoricoxib Impurity 9 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, to ensure it meets the high standards required for use as a pharmaceutical reference material. Certificates of Analysis (COA) with detailed chromatographic data are provided to support method validation and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single impurity ≤ 1.0%
Total Impurities	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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