Description

Etoricoxib Impurity 15 is a specified organic compound used as a reference standard in analytical chemistry. This impurity is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Etoricoxib during its development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments. The compound serves as an essential marker for method validation, stability studies, and impurity profiling in compliance with ICH guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Etoricoxib Impurity 15 in the API and finished drug products.
• Analytical Method Development and Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods for impurity detection and separation.
• Quality Control and Batch Release Testing: Employed in routine QC testing to monitor impurity levels and ensure batches of Etoricoxib meet stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies and Forced Degradation: Acts as a key analyte in stability-indicating methods to track impurity formation under various stress conditions (heat, light, humidity).
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research and Development: Used in synthetic chemistry research to study degradation pathways and to synthesize purer batches of the Etoricoxib API.

Basic Information

Product Name	Etoricoxib Impurity 15
CAS No.	73312-69-3
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; MK-0663 Impurity
EINECS	Contact for details

Quality Control

Every batch of Etoricoxib Impurity 15 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

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 (moisture-sensitive) nature, the container should be kept in a desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Heavy Metals	≤ 20 ppm

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