Description

Etoricoxib Impurity 13 is a high-purity 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 Etoricoxib. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for maintaining stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Etoricoxib API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles during API synthesis and formulation.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary impurity data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDA).
• Stability Studies: Employed to track the formation of degradation products in stability testing of Etoricoxib under various ICH-prescribed conditions.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Etoricoxib.

Basic Information

Product Name	Etoricoxib Impurity 13
CAS No.	1817735-82-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Etoricoxib Related Compound 13; Etoricoxib EP Impurity J; Etoricoxib USP Impurity; 5-Chloro-2-(6-methylpyridin-3-yl)-3-(4-(methylsulfonyl)phenyl)pyridine (Potential structural synonym based on class); COX-2 Inhibitor Impurity; Arcoxia Impurity 13
EINECS	Contact for details

Quality Control

Every batch of Etoricoxib Impurity 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including ICH guidelines and relevant pharmacopeial monographs (USP, EP). Comprehensive characterization is performed using advanced analytical techniques. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions if the primary container is opened repeatedly to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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