Description

Etoricoxib Impurity 11 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 quality control testing. The use of this well-characterized impurity standard is essential for meeting stringent pharmacopeial requirements and maintaining batch-to-batch consistency.

Application

• Pharmaceutical Quality Control (QC): Used as a certified reference material for the identification and quantification of specific impurities in Etoricoxib API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Stability Studies: Employed to track the formation and level of this impurity during forced degradation and long-term stability testing of drug products.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control strategies.
• Research & Development: Used in R&D laboratories to study the degradation pathways and chemical behavior of Etoricoxib.
• Pharmacopeial Testing: Applied as a reference standard to comply with testing protocols outlined in USP, EP, or other international pharmacopeias.

Basic Information

Product Name	Etoricoxib Impurity 11
CAS No.	202409-31-2
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; Etoricoxib Process Impurity; COX-2 Inhibitor Impurity; 5-Chloro-3-[4-(methylsulfonyl)phenyl]-2-(6-methyl-3-pyridinyl)pyridine; Etoricoxib Degradant; Arcoxia Impurity
EINECS	Contact for details

Quality Control

Every batch of Etoricoxib Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.