Description

Etoricoxib Impurity 7 is a specified organic impurity used as a reference standard in the analytical profiling of the active pharmaceutical ingredient (API) Etoricoxib. This compound is critical for pharmaceutical quality control and regulatory compliance, ensuring the purity and safety of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, validation, and stability studies for COX-2 inhibitor medications.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Etoricoxib API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating chromatographic methods to monitor impurity profiles during API synthesis and formulation.
• Stability Studies & Forced Degradation: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Quality Control & Batch Release Testing: A key component in the routine QC testing of Etoricoxib batches to ensure compliance with pharmacopeial limits (e.g., ICH Q3A/B).
• Regulatory Documentation & Submission: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities.
• Research on Metabolic Pathways: Can be utilized in studies investigating the metabolism and pharmacokinetics of Etoricoxib.

Basic Information

Product Name	Etoricoxib Impurity 7
CAS No.	646459-39-4
Molecular Formula	C18H15ClN2O2S
Molecular Weight	358.84 g/mol
Synonyms	5-Chloro-2-(6-methylpyridin-3-yl)-3-[4-(methylsulfonyl)phenyl]pyridine; Etoricoxib Related Compound 7; Etoricoxib Impurity C; 5-Chloro-3-[4-(methylsulfonyl)phenyl]-2-(6-methyl-3-pyridinyl)pyridine; ARCOXIA Impurity 7; 646459-39-4; UNII-6J1K9V305U
EINECS	Contact for details

Quality Control

Every batch of Etoricoxib Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances.

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 (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	97.0% - 102.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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