Description

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

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Etoricoxib Impurity J in Etoricoxib API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to monitor impurity profiles.
• Stability Indicating Method: Used in forced degradation and long-term stability studies to track the formation of this specific impurity over time.
• Quality Control & Batch Release Testing: A critical component in the QC testing protocol to ensure each batch of Etoricoxib meets stringent pharmacopeial (e.g., USP, EP) or internal specification limits.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary data on impurity identification and control strategies.
• Research into Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Etoricoxib under various stress conditions.

Basic Information

Item	Detail
Product Name	Etoricoxib Impurity J
CAS No.	646459-45-2
Molecular Formula	C18H15ClN2O2S
Molecular Weight	358.84 g/mol
Synonyms	5-Chloro-2-(6-chloropyridin-3-yl)-3-(4-methylsulfonylphenyl)pyridine; 5-Chloro-3-[4-(methylsulfonyl)phenyl]-2-(6-chloropyridin-3-yl)pyridine; Etoricoxib Related Compound J; Etoricoxib Impurity 10; Etoricoxib Chloro Impurity; Arcoxia Impurity J; MK-0663 Impurity J
EINECS	Contact for details

Quality Control

Every batch of Etoricoxib Impurity J is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data, including HPLC purity, identity confirmation (IR, MS), and impurity profile, to ensure it meets the exacting standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) with batch-specific results is supplied with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The compound is light-sensitive; prolonged exposure to light should be avoided.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
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.