Description

Etravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used in antiretroviral therapy. This high-purity active pharmaceutical ingredient is critical for the formulation of effective HIV-1 treatment regimens, particularly for patients with resistance to first-line NNRTIs. It is essential for pharmaceutical manufacturers and research institutions developing and producing advanced antiviral medications.

Application

• Pharmaceutical Formulation: Primary active ingredient in the manufacture of antiretroviral tablets for the treatment of HIV-1 infection.
• Combination Therapy: Used in fixed-dose combination (FDC) drugs alongside other antiretroviral agents for enhanced therapeutic efficacy.
• Drug-Resistant HIV Treatment: Key component in second-line and salvage therapy regimens for patients with documented NNRTI resistance.
• Research & Development: Reference standard and building block in virology research for studying novel NNRTI mechanisms and resistance profiles.
• Clinical Trial Materials: Sourced for the production of investigational new drugs (INDs) in clinical studies for next-generation HIV therapies.
• Generic Drug Manufacturing: Sourced by generic pharmaceutical companies for the production of bioequivalent versions of branded etravirine medications.

Basic Information

Product Name	Etravirine
CAS No.	269055-15-4
Molecular Formula	C20H15BrN6O
Molecular Weight	435.28 g/mol
Synonyms	4-[[6-Amino-5-bromo-2-[(4-cyanophenyl)amino]-4-pyrimidinyl]oxy]-3,5-dimethylbenzonitrile; TMC125; R-165335; Intelence (Brand Name); Etravirinum; Etravirina
EINECS	Contact for details

Quality Control

Our Etravirine is manufactured under strict quality management systems. Each batch is tested to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH Q7 guidelines for active pharmaceutical ingredients (APIs). A comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and microbiological quality is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). Keep the container in a dry, well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Water Content (KF)	NMT 1.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C
Microbiological Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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