Description

Etoricoxib Impurity CAS NO 1350206-14-2 is a high-purity chemical reference standard critical for analytical and regulatory purposes in the pharmaceutical industry. This compound is essential for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Etoricoxib by enabling precise identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions engaged in method development, stability studies, and regulatory compliance. The availability of a well-characterized impurity standard is fundamental for meeting stringent pharmacopeial requirements and maintaining robust manufacturing processes.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material for the identification and quantification of specific impurities in Etoricoxib API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods in compliance with ICH guidelines.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to monitor impurity levels against established specifications, ensuring batch-to-batch consistency.
• Stability Studies: Used to track the formation and levels of this impurity over time under various stress conditions (e.g., heat, humidity, light) as part of drug product stability programs.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research and Development: Supports synthetic route development and process optimization by helping chemists understand and control impurity formation during API synthesis.

Basic Information

Item	Detail
Product Name	Etoricoxib Impurity
CAS No.	1350206-14-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Etoricoxib Related Compound; Etoricoxib Process Impurity; 5-Chloro-2-(6-methylpyridin-3-yl)-3-(4-(methylsulfonyl)phenyl)pyridine (IUPAC name to be confirmed); Etoricoxib Specified Impurity; COX-2 Inhibitor Impurity; Arcoxia Impurity; MK-0663 Impurity
EINECS	Contact for details

Quality Control

Every batch of Etoricoxib Impurity CAS NO 1350206-14-2 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and strength, aligning with current industry standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced chromatographic and spectroscopic analyses. Our quality commitment supports compliance with cGMP and relevant pharmacopeial guidelines.

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 nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which could affect stability and purity. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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