Description

Etoricoxib Impurity 39 is a designated reference 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 marker for identifying and quantifying process-related impurities during drug development and production. Professionals in pharmaceutical R&D, quality assurance, and contract research organizations require this high-purity standard to meet stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the calibration of analytical instruments (HPLC, LC-MS) in API quality control.
• Method Development and Validation: Essential for developing, validating, and transferring analytical methods for Etoricoxib and related drug products.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used to monitor impurity profiles in Etoricoxib formulations under various stability-indicating conditions.
• Process Chemistry Optimization: Helps identify and control the formation of this specific impurity during the synthesis and purification stages of Etoricoxib manufacturing.
• Contract Research and Testing: A vital reagent for third-party testing laboratories offering analytical services to the pharmaceutical industry.

Basic Information

Item	Detail
Product Name	Etoricoxib Impurity 39
CAS No.	107825-28-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	5-Chloro-6'-methyl-3-[4-(methylsulfonyl)phenyl]-2,3'-bipyridine; Etoricoxib Related Compound 39; Etoricoxib Impurity K; Etoricoxib Process Impurity; 2,3'-Bipyridine, 5-chloro-6'-methyl-3-[4-(methylsulfonyl)phenyl]-; COX-2 Inhibitor Impurity; Arcoxia Impurity
EINECS	Contact for details

Quality Control

Every batch of Etoricoxib Impurity 39 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards for reference materials. Certificates of Analysis (COA) are available upon request, providing detailed chromatographic purity, identity confirmation (by IR, NMR, MS), and quantitative assay data. We support compliance with ICH Q3A/B and pharmacopeial guidelines.

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 must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or 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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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