Description

Darunavir-D9 is a deuterated internal standard of the antiretroviral drug Darunavir, specifically designed for analytical applications. This high-purity compound is essential for ensuring accurate quantification and method validation in complex biological matrices. It is primarily used by pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control departments for precise pharmacokinetic studies and bioanalytical method development.

Application

• Bioanalytical Method Development: Serves as a critical internal standard for the development and validation of LC-MS/MS methods for Darunavir quantification.
• Pharmacokinetic and Metabolism Studies: Enables accurate measurement of Darunavir concentration in plasma, serum, and other biological fluids during drug metabolism and pharmacokinetics (DMPK) research.
• Clinical Trial Support: Used in the bioanalysis of samples from clinical trials to ensure reliable and reproducible data on drug exposure and efficacy.
• Forensic and Anti-Doping Analysis: Supports precise detection and quantification protocols in specialized testing environments.
• Pharmaceutical Quality Control: Acts as a reference standard for impurity profiling and assay verification of Darunavir active pharmaceutical ingredient (API) and finished dosage forms.

Basic Information

Product Name	Darunavir-D9
CAS No.	1133378-37-6
Molecular Formula	C₂₇H₃₈D₉N₃O₇S
Molecular Weight	Approx. 556.76 g/mol
Synonyms	Darunavir-d9; [D9]-Darunavir; (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-d9; TMC114-d9; Prezista-d9 (deuterated standard); Darunavir Deuterated Standard; Darunavir Internal Standard
EINECS	Contact for details

Quality Control

Every batch of Darunavir-D9 is manufactured under strict quality management systems and undergoes comprehensive analytical testing. We guarantee high chemical purity and isotopic enrichment suitable for sensitive mass spectrometry applications. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity (by HPLC), isotopic purity, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C (refrigerated) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC/MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 99.0 atom % D
Chemical Purity (by HPLC)	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH limits

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