Description

Etoricoxib Impurity 47 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Etoricoxib. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Etoricoxib API and finished drug products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Etoricoxib formulations under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Chemical Research & Synthesis: Acts as a key intermediate or reference compound in organic synthesis and process chemistry research related to COX-2 inhibitors.
• Quality Control & Assurance: Provides a benchmark for in-house quality control testing to ensure batch-to-batch consistency and purity of the API.

Basic Information

Product Name	Etoricoxib Impurity 47
CAS No.	2241145-66-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Etoricoxib Related Compound 47; Etoricoxib EP Impurity 47; Etoricoxib USP Impurity 47; 5-Chloro-2-(6-methylpyridin-3-yl)-3-(4-(methylsulfonyl)phenyl)pyridine (Potential IUPAC); Arcoxia Impurity 47; COX-2 Inhibitor Impurity; 2241145-66-2
EINECS	Contact for details

Quality Control

Every batch of Etoricoxib Impurity 47 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity levels is provided with each shipment to guarantee traceability and reliability for your critical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
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.