Description

Rilpivirine Hcl CAS NO 700361-47-3 is the hydrochloride salt form of Rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI). This high-purity active pharmaceutical ingredient (API) is critical for ensuring the efficacy and safety of antiviral medications. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of antiretroviral therapies for the treatment of HIV-1 infection.

Application

• Pharmaceutical API: Primary active ingredient in the formulation of antiretroviral tablets and combination therapies for HIV-1.
• Drug Substance Manufacturing: Serves as the key chemical entity in the final synthesis and scale-up of Rilpivirine-based finished dosage forms.
• Research & Development: Used in preclinical and clinical studies to investigate new formulations, delivery mechanisms, or combination regimens.
• Reference Standard: Employed as a high-purity standard in analytical laboratories for quality control, method development, and validation of related drug products.
• Regulatory Submissions: Supplied as a well-characterized drug substance to support regulatory filings (e.g., DMF, CMC sections) with agencies like the FDA and EMA.

Basic Information

Item	Details
Product Name	Rilpivirine Hydrochloride
CAS No.	700361-47-3
Molecular Formula	C22H19N6·HCl
Molecular Weight	402.88 g/mol (Free base: 366.42 g/mol)
Synonyms	Rilpivirine HCl; Rilpivirine Hydrochloride; TMC278; 4-[[4-[[4-[(E)-2-Cyanoethenyl]-2,6-dimethylphenyl]amino]pyrimidin-2-yl]amino]benzonitrile monohydrochloride; Edurant (as drug product); NNRTI TMC278; RPV HCl
EINECS	Contact for details

Quality Control

Our Rilpivirine Hydrochloride is manufactured under strict quality systems. We provide material that meets or exceeds relevant pharmacopeial standards, with comprehensive testing to ensure identity, purity, and potency. A Certificate of Analysis (COA) detailing specifications such as assay, related substances, residual solvents, and microbiological quality is provided with each batch to support your regulatory and manufacturing requirements.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF)	≤ 1.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Microbial Limits	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.