Description

Etravirine-13C3 is a stable isotope-labeled analog of the non-nucleoside reverse transcriptase inhibitor (NNRTI) Etravirine, where three carbon atoms are replaced with the carbon-13 (13C) isotope. This compound is essential as an internal standard for the precise and accurate quantification of Etravirine in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is a critical tool for pharmaceutical research and development laboratories, contract research organizations (CROs), and bioanalytical service providers focused on antiviral drug metabolism, pharmacokinetic (PK) studies, and therapeutic drug monitoring.

Application

• Bioanalytical Internal Standard: Primary use as a stable isotope-labeled internal standard in Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) for the absolute quantification of Etravirine in plasma, serum, and other biological fluids.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Research: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical studies for HIV treatment regimens.
• Metabolite Identification and Profiling: Aids in the identification and structural elucidation of Etravirine metabolites using mass spectrometry, supporting drug safety and metabolism studies.
• Method Development and Validation: Critical for developing, optimizing, and validating robust, regulatory-compliant (FDA, EMA) bioanalytical methods in Good Laboratory Practice (GLP) environments.
• Therapeutic Drug Monitoring (TDM): Supports assays designed to monitor Etravirine concentration in patients to ensure therapeutic efficacy and minimize toxicity or virological failure.
• Reference Material for Quality Control: Serves as a high-purity certified reference material (CRM) for calibrating instruments and ensuring data integrity in analytical laboratories.

Basic Information

Product Name	Etravirine-13C3
CAS No.	1189671-48-4
Molecular Formula	C2013C3H15BrN6O3
Molecular Weight	~444.27 g/mol (for 13C3 labeled form)
Synonyms	4-[[6-Amino-5-bromo-2-[(4-cyanophenyl)amino]-4-pyrimidinyl]oxy]-3,5-dimethylbenzonitrile-13C3; TMC125-13C3; Intelence-13C3; (4-[[6-Amino-5-bromo-2-[(4-cyanophenyl)amino]pyrimidin-4-yl]oxy]-3,5-dimethylbenzonitrile-13C3); Etravirine (13C3); NNRTI-13C3 Internal Standard; Stable Isotope Labeled Etravirine
EINECS	Contact for details

Quality Control

Our Etravirine-13C3 is manufactured under strict quality systems to ensure the high chemical purity and isotopic enrichment required for sensitive mass spectrometry applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (HPLC), isotopic purity (13C content), and chemical purity. We support regulatory compliance for pharmaceutical research, and our quality commitment aligns with the standards expected in GLP and cGMP environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). For long-term stability, consider storage at -20°C in a desiccated environment. The product is hygroscopic (moisture-sensitive).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC-MS)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (13C)	≥99 atom % 13C
Isotopic Enrichment	≥98% (CP 13C3)
Chemical Purity	≥95%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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