Description

Etoricoxib Impurity Q is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Etoricoxib, a selective COX-2 inhibitor. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The compound is supplied with comprehensive analytical data to support stringent compliance requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Etoricoxib Impurity Q in Etoricoxib API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities during API synthesis and formulation.
• Quality Control & Assurance: A critical tool for in-process testing and release testing of Etoricoxib batches to ensure compliance with pharmacopeial limits (e.g., ICH Q3A/B).
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions to determine product shelf-life.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Used in metabolic and pharmacokinetic studies to understand the degradation pathways of Etoricoxib.

Basic Information

Product Name	Etoricoxib Impurity Q
CAS No.	292067-97-1
Molecular Formula	C18H15ClN2O2S
Molecular Weight	358.84 g/mol
Synonyms	5-Chloro-2-(6-methylpyridin-3-yl)-3-(4-methylsulfonylphenyl)pyridine; 5-Chloro-3-[4-(methylsulfonyl)phenyl]-2-(6-methyl-3-pyridinyl)pyridine; Etoricoxib Related Compound Q; Etoricoxib Impurity 5; Etoricoxib EP Impurity Q; Etoricoxib USP Impurity Q; Arcoxia Impurity Q
EINECS	Contact for details

Quality Control

Every batch of Etoricoxib Impurity Q is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identity, purity, and impurity profile by validated chromatographic methods. We support compliance with USP, EP, and other pharmacopeial monographs.

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 in a desiccated environment to maintain stability and purity. Keep the container tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white powder
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
Water Content (KF)	≤ 1.0%
Heavy Metals	≤ 20 ppm

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