Description

Etravirine n-Oxide is a key pharmaceutical intermediate and metabolite of the antiretroviral drug Etravirine. This compound is of significant importance for research and development in the field of HIV treatment, particularly for metabolic studies and impurity profiling. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on antiviral drug development and quality control.

Application

• Pharmaceutical Intermediate: Critical for the synthesis and development of next-generation non-nucleoside reverse transcriptase inhibitors (NNRTIs).
• Reference Standard: Used as a certified reference material (CRM) for the analytical quantification of Etravirine and its related substances in drug substances and products.
• Metabolite Studies: Essential for in-vitro and in-vivo pharmacokinetic and metabolic pathway research for Etravirine.
• Impurity Profiling: Serves as a specified impurity standard to ensure the purity and safety of Etravirine active pharmaceutical ingredients (APIs) per ICH guidelines.
• Bioanalytical Research: Employed in method development and validation for LC-MS/MS and HPLC analyses in biological matrices.
• Regulatory Compliance: Supports regulatory filings (e.g., FDA, EMA) by providing necessary data on drug degradation and metabolism.

Basic Information

Product Name	Etravirine n-Oxide
CAS No.	907180-19-2
Molecular Formula	C20H15BrN6O2
Molecular Weight	451.28 g/mol
Synonyms	4-[[6-Amino-5-bromo-2-[(4-cyanophenyl)amino]-4-pyrimidinyl]oxy]-3,5-dimethylbenzonitrile N-Oxide; TMC125 n-Oxide; Etravirine Metabolite; Etravirine N-Oxide Impurity; Intelence n-Oxide; R165335 n-Oxide; 907180-19-2
EINECS	Contact for details

Quality Control

Our Etravirine n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and stringent control of residual solvents and heavy metals. We provide full traceability and Certificates of Analysis (COA) are available for all shipments, ensuring compliance with relevant pharmacopeial and ICH Q3A/B guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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