Description

(1R,2S)-Darunavir CAS NO 1402142-63-5 is a high-purity stereoisomer of the potent HIV-1 protease inhibitor Darunavir. This specific enantiomer is of critical importance in pharmaceutical research and development for studying structure-activity relationships and metabolic pathways. It serves as a key intermediate and reference standard for analytical method development and quality control in the production of antiviral therapeutics. Organizations engaged in advanced drug discovery, process chemistry, and regulatory compliance for antiretroviral medications require this precisely defined compound.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification, assay, and impurity profiling of Darunavir in active pharmaceutical ingredient (API) and finished dosage forms.
• Drug Discovery & Development: Serves as a critical intermediate and building block in the research and synthesis of novel protease inhibitors and related antiviral compounds.
• Metabolic and Pharmacokinetic Studies: Employed in in vitro and in vivo studies to investigate the stereoselective metabolism, bioavailability, and efficacy of Darunavir enantiomers.
• Analytical Method Development: Essential for developing and validating chiral separation methods using techniques like HPLC and CE to ensure enantiomeric purity.
• Process Chemistry & Optimization: Used to optimize asymmetric synthesis routes and purification processes for the commercial manufacture of Darunavir.
• Regulatory Compliance & Documentation: Provides a definitive standard for regulatory filings (e.g., with FDA, EMA) to demonstrate control over the stereochemistry of the final API.

Basic Information

Item	Details
Product Name	(1R,2S)-Darunavir
CAS No.	1402142-63-5
Molecular Formula	C27H37N3O7S
Molecular Weight	547.67 g/mol
Synonyms	(1R,2S)-Darunavir; (1R,2S)-TMC-114; [(1R,2S)-2-Hydroxy-1-(phenylmethyl)propyl] N-[(2S,3R)-4-[(4-aminophenyl)sulfonyl-(2-methylpropyl)amino]-3-hydroxy-1-phenyl-2-butyl]carbamate; (1R,2S)-HIV Protease Inhibitor TMC114; Darunavir Enantiomer; Darunavir Stereoisomer; Prezista® Enantiomer (related to trade name)
EINECS	Contact for details

Quality Control

Our (1R,2S)-Darunavir is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and strength, meeting the stringent requirements for pharmaceutical reference standards and intermediates. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for chiral purity, assay, residual solvents, and related substances by validated methods such as chiral HPLC. We support compliance with cGMP, ICH Q7, and other relevant pharmaceutical guidelines.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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%
Chiral Purity (Chiral HPLC)	≥99.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤0.5%

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