Description

Etoricoxib Impurity 29 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Etoricoxib by accurately identifying and quantifying related substances. It is an essential tool for analytical chemists and quality assurance professionals in the pharmaceutical and contract research organization (CRO) sectors. The material is supplied with comprehensive analytical data to support regulatory filings and internal method validation.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Etoricoxib API batches.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Stability Studies: Used as a marker to track the formation of degradation products in Etoricoxib formulations under various stress conditions.
• Research and Development: Facilitates chemical research into the synthesis pathways and degradation mechanisms of Etoricoxib.

Basic Information

Item	Detail
Product Name	Etoricoxib Impurity 29
CAS No.	1798110-01-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Etoricoxib Related Compound 29; Etoricoxib EP Impurity K; Etoricoxib USP Related Substance 29; 5-Chloro-2-(6-methylpyridin-3-yl)-3-(4-(methylsulfonyl)phenyl)pyridine; ARCOXIA Impurity 29; COX-2 Inhibitor Impurity; 1798110-01-6
EINECS	Contact for details

Quality Control

Every batch of Etoricoxib Impurity 29 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for assay, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated place. Handle and store in accordance with good laboratory practices.

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 individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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