Description

Etoricoxib Impurity 18 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

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Etoricoxib API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to accurately identify and quantify this specific impurity.
• Stability Studies: Employed to monitor the formation and level of this impurity during forced degradation and long-term stability testing of Etoricoxib products.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development: Used in R&D laboratories to study the degradation pathways, synthesis impurities, and metabolic profiles of Etoricoxib.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability standard and for routine batch analysis in pharmaceutical QC laboratories to ensure product specifications are met.

Basic Information

Product Name	Etoricoxib Impurity 18
CAS No.	1027162-35-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	5-Chloro-2-(6-methylpyridin-3-yl)-3-(4-(methylsulfonyl)phenyl)pyridine; Etoricoxib Related Compound 18; Etoricoxib Impurity K; Etoricoxib EP Impurity K; Etoricoxib Process Impurity; ARCOXIA Impurity 18
EINECS	Contact for details

Quality Control

Every batch of Etoricoxib Impurity 18 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 pharmacopeial standards (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, cool place. The material is light-sensitive and should be handled under appropriate conditions 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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.