Description

Etoricoxib Impurity 12 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 ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance of COX-2 inhibitor medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Etoricoxib Impurity 12 in API and finished drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS.
• Quality Control (QC) Testing: Employed in routine QC testing of Etoricoxib batches to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability studies of Etoricoxib formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity profiling and control strategies.
• Research and Development: Supports synthetic route optimization and impurity fate and tolerance studies during the API development process.

Basic Information

Item	Details
Product Name	Etoricoxib Impurity 12
CAS No.	646459-41-8
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 12; Etoricoxib Impurity C; Etoricoxib EP Impurity C; Etoricoxib USP Impurity; ARCOXIA Impurity 12
EINECS	Contact for details

Quality Control

Our Etoricoxib Impurity 12 is manufactured under strict quality systems to ensure batch-to-batch consistency and reliability. Each lot undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with ICH guidelines. We support compliance with cGMP, USP, and EP standards for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material should be kept in a cool, dry, and well-ventilated area. Avoid exposure to excessive heat and moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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