Description

Etoricoxib Impurity 8 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Etoricoxib. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It serves as a key reference material for method development, validation, and routine batch testing in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Etoricoxib Impurity 8 in API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Etoricoxib.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels and ensure batches meet pharmacopeial specifications (e.g., ICH Q3A/B).
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), ANDAs, and other regulatory filings with agencies like the FDA and EMA.
• Research & Development: Used in R&D to understand the degradation pathways and synthesis by-products of Etoricoxib.

Basic Information

Product Name	Etoricoxib Impurity 8
CAS No.	1421227-97-5
Molecular Formula	C18H15ClN2O2S
Molecular Weight	358.84 g/mol
Synonyms	5-Chloro-2-(6-chloropyridin-3-yl)-3-(4-methylsulfonylphenyl)pyridine; 5-Chloro-3-[4-(methylsulfonyl)phenyl]-2-(6-chloropyridin-3-yl)pyridine; Etoricoxib Related Compound 8; Etoricoxib EP Impurity I; Etoricoxib Process Impurity; ARCOXIA Impurity 8
EINECS	Contact for details

Quality Control

Our Etoricoxib Impurity 8 is manufactured and tested under strict quality management systems. Each batch is characterized and qualified using advanced analytical techniques including HPLC, GC, MS, and NMR to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile. Our quality standards align with ICH guidelines and support compliance in cGMP environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Assay	97.0% - 102.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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