Description

Darunavir is a potent, non-peptidic protease inhibitor specifically designed for the treatment of Human Immunodeficiency Virus (HIV-1) infection. Its core value proposition lies in its high efficacy against both wild-type and multi-drug-resistant strains of HIV-1, making it a critical component in modern antiretroviral therapy (ART) regimens. This active pharmaceutical ingredient (API) is essential for pharmaceutical manufacturers developing combination therapies for global healthcare markets.

Application

• Primary Active Pharmaceutical Ingredient (API) in antiretroviral medications for HIV-1 treatment.
• Key component in fixed-dose combination (FDC) tablets with other antiretrovirals like cobicistat, tenofovir, and emtricitabine.
• Manufacturing of generic and branded pharmaceutical formulations for global distribution.
• Research and development of new and improved antiretroviral drug combinations.
• Use in clinical studies and trials for HIV/AIDS therapeutic advancements.
• Production of pediatric and adult dosage forms, including tablets and oral suspensions.

Basic Information

Product Name	Darunavir
CAS No.	1526916-57-3
Molecular Formula	C₂₇H₃₇N₃O₇S
Molecular Weight	547.66 g/mol
Synonyms	Darunavir Ethanolate; TMC114; UIC-94017; (3R,3aS,6aR)-Hexahydrofuro[2,3-b]furan-3-yl (1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propylcarbamate; Prezista (Brand Name); DRV
EINECS	Contact for details

Quality Control

Our Darunavir is manufactured under strict quality management systems. We ensure compliance with current Good Manufacturing Practices (cGMP) and relevant pharmacopeial standards (USP/EP). Every batch undergoes rigorous analytical testing, including identification, assay, impurity profiling, and residual solvent analysis. A comprehensive Certificate of Analysis (COA) is provided with each shipment to guarantee purity, identity, and safety.

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 in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Microbial Enumeration	Complies with USP <61> / Ph. Eur. 2.6.12

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