Description

Etravirine Impurity 11 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for the accurate identification, quantification, and monitoring of process-related impurities in the active pharmaceutical ingredient Etravirine, ensuring final drug product safety and regulatory compliance. It is an essential material for analytical laboratories, quality assurance departments, and research scientists within the pharmaceutical and biotechnology industries.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for analytical method development and validation.
• Quality Control & Assurance: For the identification and quantification of this specific impurity in Etravirine API batches to ensure compliance with ICH guidelines.
• Regulatory Submissions: Supporting documentation for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used as a marker to track impurity profiles during forced degradation and long-term stability testing of drug substances and products.
• Process Chemistry R&D: Aiding in the optimization of synthetic routes and purification processes to minimize impurity formation.
• Pharmacopoeial Testing: Potential use in compliance testing against standards set by USP, EP, or other pharmacopoeias.

Basic Information

Product Name	Etravirine Impurity 11
CAS No.	1398507-09-9
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; TMC125 Impurity 11; Etravirine Related Compound 11; (4-((6-Amino-5-bromo-2-((4-cyanophenyl)amino)pyrimidin-4-yl)oxy)-3,5-dimethylbenzonitrile); UNII-9C6J7H9V2F; 9C6J7H9V2F; 4-((6-Amino-5-bromo-2-((4-cyanophenyl)amino)pyrimidin-4-yl)oxy)-3,5-dimethylbenzonitrile
EINECS	Contact for details

Quality Control

Every batch of Etravirine Impurity 11 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, NMR, and MS to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against established specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a 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, which may affect stability and purity. Long-term storage under inert atmosphere is recommended.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum corresponds to 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)	≤ 1.0% w/w
Assay	97.0% - 103.0% (on anhydrous basis)

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