Description

Darunavir Ethanolate is a high-purity pharmaceutical intermediate and active pharmaceutical ingredient (API) primarily used in the synthesis of antiretroviral medications. Its value lies in its critical role as the ethanolate salt form of Darunavir, offering enhanced stability and handling properties for downstream pharmaceutical manufacturing. This compound is essential for research institutions, generic drug manufacturers, and pharmaceutical companies engaged in the development and production of HIV protease inhibitors.

Application

• Active Pharmaceutical Ingredient (API) for the formulation of Darunavir-based antiretroviral drugs.
• Key Intermediate in the synthesis and scale-up production of HIV-1 protease inhibitors.
• Reference Standard for analytical method development and quality control in pharmaceutical laboratories.
• Research & Development of novel antiviral therapies and combination drug products.
• Generic Drug Manufacturing, supporting the production of cost-effective HIV treatment options.

Basic Information

Product Name	Darunavir Ethanolate
CAS No.	635728-49-3
Molecular Formula	C27H37N3O7S • C2H5OH
Molecular Weight	593.71 g/mol (for the ethanolate complex)
Synonyms	Darunavir Ethanol Solvate; TMC-114 Ethanolate; (3R,3aS,6aR)-Hexahydrofuro[2,3-b]furan-3-yl (1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propylcarbamate ethanolate; Darunavir Ethanol Solvate; Prezista® Intermediate; UIC-94017 Ethanolate
EINECS	Contact for details

Quality Control

Our Darunavir Ethanolate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are provided with every shipment to guarantee traceability and compliance with relevant guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment to prevent degradation.

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%
Water Content (KF)	≤2.0%
Residue on Ignition	≤0.1%
Related Substances (HPLC)	Individual impurity: ≤0.5%; Total impurities: ≤2.0%
Ethanol Content (GC)	As per stoichiometry

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