Description

D-Darunavir CAS NO 1399859-60-9 is a high-purity, non-natural stereoisomer of the antiretroviral drug Darunavir. This compound is of significant value as a critical reference standard and a key chiral intermediate in pharmaceutical research and development. It is essential for analytical method development, quality control, and process chemistry studies within the pharmaceutical industry. Researchers and manufacturers rely on this material for impurity profiling, chiral separation studies, and the synthesis of novel drug candidates.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification, assay, and impurity testing of Darunavir active pharmaceutical ingredients (APIs) and finished dosage forms.
• Chiral Analytical Method Development: Serves as a critical component in developing and validating chiral HPLC or SFC methods to separate and quantify stereoisomeric impurities.
• Process Chemistry & Impurity Synthesis: Acts as a building block or a precursor for synthesizing specific stereoisomeric impurities required for regulatory filing and toxicology studies.
• Metabolism and Pharmacokinetics (DMPK) Studies: Employed in research to understand the metabolic pathways and chiral inversion properties of Darunavir and related compounds.
• Academic and Institutional Research: Utilized in universities and research institutes for studying protease inhibitor mechanisms, resistance, and the development of next-generation HIV therapeutics.

Basic Information

Product Name	D-Darunavir
CAS No.	1399859-60-9
Molecular Formula	C27H37N3O7S
Molecular Weight	547.67 g/mol
Synonyms	(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; D-Enantiomer of Darunavir; (R)-Darunavir; Darunavir Impurity; UNII-1ZQ8N8Z4VQ; TMC-126 D-isomer; Anti-HIV Protease Inhibitor D-isomer
EINECS	Contact for details

Quality Control

Our D-Darunavir is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chiral purity verification by HPLC, to ensure it meets the high standards required for pharmaceutical research. A detailed Certificate of Analysis (COA) providing batch-specific data for identity, purity, and chiral excess is supplied with every order.

Storage

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

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 guidelines
Water Content (KF)	≤ 1.0%

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