Description

Etoricoxib Impurity 42 is a high-purity 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 research laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized in the development and validation of analytical methods, stability studies, and the establishment of impurity profiles for Etoricoxib-based drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of Etoricoxib Impurity 42 in API and finished drug products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, and other chromatographic methods for impurity detection.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor and control impurity levels against ICH guidelines.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug shelf-life studies.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to develop purification processes for Etoricoxib.

Basic Information

Product Name	Etoricoxib Impurity 42
CAS No.	321913-54-6
Molecular Formula	C18H15ClN2O2S
Molecular Weight	358.84 g/mol
Synonyms	5-Chloro-2-(6-methylpyridin-3-yl)-3-[4-(methylsulfonyl)phenyl]pyridine; Etoricoxib Related Compound 42; Etoricoxib EP Impurity B; Etoricoxib USP Impurity; 5-Chloro-3-[4-(methylsulfonyl)phenyl]-2-(6-methyl-3-pyridinyl)pyridine; ARCOXIA Impurity; MK-0663 Impurity
EINECS	Contact for details

Quality Control

Every batch of Etoricoxib Impurity 42 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, confirming its suitability for use as a reference standard.

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 hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
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)	≤ 1.0% w/w
Assay (on dried basis)	97.0% - 102.0%

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