Description

1-Epi-Darunavir is a key stereoisomer and pharmaceutical intermediate of the antiretroviral drug Darunavir. This high-purity compound is critical for research and development in the synthesis and impurity profiling of HIV protease inhibitors. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and advanced chemical manufacturers focused on antiviral drug development and quality control.

Application

• Pharmaceutical Reference Standard: Serves as a critical impurity standard for the analytical method development and validation of Darunavir API and finished dosage forms.
• Process Chemistry Research: Used in stereochemical studies and route scouting for the optimization of Darunavir synthesis pathways.
• Metabolite and Degradation Studies: Employed in stability testing and metabolic pathway identification for antiviral drug formulations.
• Quality Control & Assurance: Essential for HPLC, LC-MS, or NMR analysis to quantify and control the isomeric purity of Darunavir batches.
• Academic Research: Used in universities and research institutes for studies on HIV protease inhibitor structure-activity relationships (SAR).
• Regulatory Compliance: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized materials for impurity identification and control strategies.

Basic Information

Item	Details
Product Name	1-Epi-Darunavir
CAS No.	1546918-95-9
Molecular Formula	C₂₇H₃₇N₃O₇S
Molecular Weight	547.67 g/mol
Synonyms	Darunavir Epimer; (3R,3aS,6aR)-Hexahydrofuro[2,3-b]furan-3-yl N-[(2S,3R)-4-[(4-aminophenyl)sulfonyl-(2-methylpropyl)amino]-3-hydroxy-1-phenylbutan-2-yl]carbamate; TMC-126 Epimer; UIC-94017 Epimer; 1-Epimer of Darunavir
EINECS	Contact for details

Quality Control

Our 1-Epi-Darunavir is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and chiral analysis for isomeric content, to ensure it meets the high standards required for pharmaceutical research and development. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Isomeric Purity (Chiral HPLC)	≥ 99.0% (1-Epi-Darunavir)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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