Description

Darunavir o-β-D-Glucuronide is a key metabolite and reference standard of the antiretroviral drug Darunavir, formed via glucuronidation. This compound is essential for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics (PK), and bioanalytical method validation. It is primarily utilized by research institutions, pharmaceutical companies, and contract research organizations (CROs) engaged in the development and quality control of HIV therapeutics.

Application

• Metabolite Reference Standard: Serves as a critical certified standard for the identification and quantification of Darunavir metabolites in biological matrices during preclinical and clinical studies.
• Pharmacokinetic & DMPK Studies: Used to investigate the absorption, distribution, metabolism, and excretion (ADME) profile of Darunavir, enabling a deeper understanding of its in vivo behavior.
• Bioanalytical Method Development: Essential for developing and validating sensitive and specific HPLC-MS/MS or LC-MS methods for therapeutic drug monitoring (TDM) and bioequivalence studies.
• Drug Impurity Profiling: Acts as a known impurity or degradation product standard to ensure the purity and stability of Darunavir active pharmaceutical ingredient (API) and finished dosage forms.
• Enzyme Reaction Studies: Employed in vitro to study the activity and kinetics of UDP-glucuronosyltransferase (UGT) enzymes responsible for this phase II metabolic pathway.

Basic Information

Product Name	Darunavir o-β-D-Glucuronide
CAS No.	1159613-27-0
Molecular Formula	C31H43N3O14S
Molecular Weight	713.75 g/mol
Synonyms	Darunavir Glucuronide; Darunavir O-Glucuronide; [(1R,5S,6R)-2,8-Dioxabicyclo[3.3.0]oct-6-yl] N-[(2S,3R)-4-[(4-aminophenyl)sulfonyl-(2-methylpropyl)amino]-3-hydroxy-1-phenylbutan-2-yl]carbamate glucuronide; TMC-126 Glucuronide; Darunavir Metabolite; Darunavir O-β-D-Glucopyranosiduronic Acid; Prezista Metabolite
EINECS	Contact for details

Quality Control

Our Darunavir o-β-D-Glucuronide is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency, suitable for demanding research applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity confirmation via spectroscopic methods, and impurity profiles. We adhere to relevant industry standards for reference materials to support your regulatory and research requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, moisture-free environment. This hygroscopic and light-sensitive compound should be allowed to equilibrate to room temperature in a desiccator before opening to prevent condensation and degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥95.0%
Water Content (KF)	≤5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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