Description

Etoricoxib Impurity 38 is a designated chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Etoricoxib. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for COX-2 inhibitor medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Etoricoxib API.
• Method Development & Validation (HPLC/LC-MS): Essential for developing and validating chromatographic methods to detect and quantify this specific impurity.
• Quality Control & Batch Release: Used in routine QC testing of Etoricoxib drug substances and finished products to monitor impurity levels against ICH guidelines.
• Stability Studies: Employed to identify and track the formation of degradation products in Etoricoxib formulations under various stress conditions.
• Regulatory Compliance & Filing: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to demonstrate thorough impurity characterization.
• Research on Degradation Pathways: Aids in studying the chemical stability and degradation mechanisms of Etoricoxib.

Basic Information

Product Name	Etoricoxib Impurity 38
CAS No.	887479-63-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Etoricoxib Related Compound 38; Etoricoxib EP Impurity H; Etoricoxib USP Impurity; 5-Chloro-2-(6-methylpyridin-3-yl)-3-(4-(methylsulfonyl)phenyl)pyridine; ARCOXIA Impurity 38; MK-0663 Impurity 38; COX-2 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Etoricoxib Impurity 38 is manufactured and controlled under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, impurities, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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