Description

Rilpivirine Fumarate Salt [1:1] is a high-purity, non-nucleoside reverse transcriptase inhibitor (NNRTI) pharmaceutical intermediate. This compound is critical for the synthesis of the active pharmaceutical ingredient (API) used in modern antiretroviral therapies. It is primarily required by pharmaceutical manufacturers and advanced research institutions engaged in the development and production of HIV-1 treatment regimens.

Application

• Active Pharmaceutical Ingredient (API) Synthesis: Primary raw material for the manufacture of Rilpivirine API.
• Antiretroviral Drug Formulation: Used in the production of combination therapies for HIV-1 infection.
• Pharmaceutical Research & Development: Serves as a key intermediate in preclinical and clinical studies for new HIV treatments.
• Reference Standard: Utilized as a certified reference material (CRM) for quality control and analytical method development.
• Generic Drug Manufacturing: Essential for companies producing generic versions of NNRTI-based medications.

Basic Information

Product Name	Rilpivirine Fumarate Salt [1:1]
CAS No.	877817-88-4
Molecular Formula	C26H21N6O3 • C4H4O4
Molecular Weight	584.59 g/mol
Synonyms	Rilpivirine Fumarate; Rilpivirine Hemifumarate; TMC278 Fumarate; 4-[[4-[[4-[(E)-2-Cyanoethenyl]-2,6-dimethylphenyl]amino]pyrimidin-2-yl]amino]benzonitrile Fumarate (1:1); Edurant Intermediate; RPV Fumarate; NNRTI Rilpivirine Salt
EINECS	Contact for details

Quality Control

Our Rilpivirine Fumarate Salt [1:1] is manufactured under strict quality management systems. Each batch is tested to ensure it meets stringent specifications for identity, purity, and impurity profiles, consistent with ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and heavy metals is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Specific Rotation	Contact for details

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