Description

Etravirine Impurity CAS NO 1706943-59-0 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) Etravirine, a non-nucleoside reverse transcriptase inhibitor. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies for method development, validation, and impurity profiling studies. The availability of this well-characterized impurity is essential for meeting stringent global pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Etravirine API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels during API synthesis and purification.
• Quality Control & Assurance (QC/QA): 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 data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Stability Studies: Employed to track the formation of degradation products in Etravirine formulations under various stress conditions.
• Process Chemistry Research: Used by R&D scientists to study and optimize synthetic pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Etravirine Impurity
CAS No.	1706943-59-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Etravirine Related Compound; Etravirine Process Impurity; Etravirine Degradant; TMC125 Impurity; 4-[[6-Amino-5-bromo-2-[(4-cyanophenyl)amino]-4-pyrimidinyl]oxy]-3,5-dimethylbenzonitrile (Tentative IUPAC); INTELENCE Impurity; R165335 Impurity; 1706943-59-0
EINECS	Contact for details

Quality Control

Our Etravirine Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, spectroscopic identification (IR, NMR, MS), and residual solvent screening, to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided and traceable to primary reference standards where applicable.

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 atmosphere or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
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% w/w

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