Description

2-Epi-Darunavir is a key stereoisomer and pharmaceutical intermediate of significant importance in the research and development of antiviral therapeutics. This compound is primarily utilized as a critical reference standard and building block for the synthesis and analytical characterization of Darunavir and its related analogs. It is essential for pharmaceutical R&D laboratories, analytical testing facilities, and manufacturers focused on advancing HIV protease inhibitor development and ensuring rigorous quality control.

Application

• Pharmaceutical Reference Standard: Serves as a critical certified reference material (CRM) for the identification, purity assessment, and quantification of Darunavir in analytical methods like HPLC and LC-MS.
• Process Chemistry & Impurity Profiling: Used in the development and validation of synthetic routes for Darunavir, helping to identify, monitor, and control process-related impurities.
• Metabolite & Degradation Studies: Employed in stability testing and metabolic studies to understand the degradation pathways and biotransformation of Darunavir.
• Active Pharmaceutical Ingredient (API) Development: Acts as a strategic intermediate in the research-scale synthesis of novel Darunavir derivatives and next-generation protease inhibitors.
• Quality Assurance & Regulatory Compliance: Essential for preparing impurity specifications and supporting regulatory filings (e.g., with FDA, EMA) by providing a characterized impurity standard.

Basic Information

Product Name	2-Epi-Darunavir
CAS No.	850141-19-4
Molecular Formula	C27H37N3O7S
Molecular Weight	547.67 g/mol
Synonyms	Darunavir EP Impurity C; Darunavir Impurity C; (3R,3aS,6aR)-Hexahydrofuro[2,3-b]furan-3-yl (1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propylcarbamate; TMC-126 Epimer; UIC-94017 Epimer
EINECS	Contact for details

Quality Control

Every batch of 2-Epi-Darunavir is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and identity confirmation, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical methods is provided with each shipment to support your quality and regulatory needs.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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