Description

Etoricoxib Impurity M is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Etoricoxib. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• As a certified reference standard for the quantitative and qualitative analysis of Etoricoxib API.
• For pharmaceutical impurity profiling and identification in quality control (QC) laboratories.
• In method development and validation for HPLC, UPLC, and other chromatographic techniques.
• As a critical component in stability studies to monitor degradation pathways of Etoricoxib.
• For regulatory submissions and compliance with ICH guidelines (Q3A, Q3B) on impurities.
• Used in research and development to study the synthesis and properties of Etoricoxib-related substances.

Basic Information

Product Name	Etoricoxib Impurity M
CAS No.	307531-95-9
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-methyl-3-pyridinyl)pyridine; Etoricoxib Related Compound M; Etoricoxib Impurity 6; ARCOXIA Impurity M; MK-0663 Impurity M
EINECS	Contact for details

Quality Control

Our Etoricoxib Impurity M is manufactured under strict quality systems to ensure batch-to-batch consistency and high purity. Each lot is accompanied by a comprehensive Certificate of Analysis (COA) detailing results from advanced analytical techniques. We support compliance with ICH guidelines and can supply materials suitable for use under cGMP conditions for pharmaceutical development.

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 accordingly to maintain stability.

Specification

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

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