Description

Etoricoxib Impurity 35 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 precise characterization of this impurity is essential for maintaining the stringent purity standards demanded in modern pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Etoricoxib API and finished dosage forms.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to establish retention times, response factors, and detection limits for impurity profiling.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) that require detailed impurity identification and qualification data.
• Stability Studies: Employed to monitor the formation and levels of this specific impurity in Etoricoxib products under various storage conditions over time.
• Process Chemistry Research: Used by R&D scientists to study and optimize synthetic pathways to minimize the formation of this impurity during API manufacturing.
• Pharmacopoeial Testing: Applied as a system suitability component in tests prescribed by pharmacopoeias like USP, EP, or BP for Etoricoxib monographs.

Basic Information

Product Name	Etoricoxib Impurity 35
CAS No.	855307-79-8
Molecular Formula	C18H15ClN2O2S
Molecular Weight	358.84 g/mol
Synonyms	5-Chloro-2-(6-methylpyridin-3-yl)-3-(4-methylsulfonylphenyl)pyridine; Etoricoxib Related Compound 35; Etoricoxib EP Impurity G; Etoricoxib USP Impurity; ARCOXIA Impurity 35; 5-Chloro-3-(4-(methylsulfonyl)phenyl)-2-(6-methylpyridin-3-yl)pyridine
EINECS	Contact for details

Quality Control

Every batch of Etoricoxib Impurity 35 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request, providing detailed results for identity, purity, and impurity profile as determined by advanced chromatographic and spectroscopic techniques.

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 powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.