Description

Darunavir n-β-D-Glucuronide is a crucial metabolite and reference standard of the antiretroviral drug Darunavir. This compound is essential for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioanalytical method validation. It is primarily used by pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in the development and quality control of HIV/AIDS therapeutics.

Application

• Metabolite Reference Standard: Serves as a certified standard for the quantitative and qualitative analysis of Darunavir metabolites in biological matrices during preclinical and clinical studies.
• Pharmacokinetic & DMPK Studies: Critical for understanding the absorption, distribution, metabolism, and excretion (ADME) profile of Darunavir.
• Bioanalytical Method Development: Used to develop and validate sensitive HPLC, LC-MS, or LC-MS/MS methods for therapeutic drug monitoring and regulatory submissions.
• Impurity Profiling: Employed as an impurity marker in the stability testing and quality control of Darunavir active pharmaceutical ingredient (API) and finished dosage forms.
• Drug-Drug Interaction Studies: Utilized in research investigating metabolic pathways and potential interactions with other co-administered drugs.
• Regulatory Compliance: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization of a major human metabolite.

Basic Information

Product Name	Darunavir n-β-D-Glucuronide
CAS No.	1159613-25-8
Molecular Formula	C31H43N3O14S
Molecular Weight	713.75 g/mol
Synonyms	Darunavir Glucuronide; Darunavir N-Glucuronide; Darunavir β-D-Glucuronide; (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 β-D-Glucopyranosiduronic acid; TMC-126 Glucuronide; UIC-94017 Glucuronide
EINECS	Contact for details

Quality Control

Our Darunavir n-β-D-Glucuronide is manufactured under strict quality systems suitable for research and analytical applications. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (NMR, MS), to ensure high batch-to-batch consistency and reliability. A detailed Certificate of Analysis (COA) providing lot-specific data is supplied with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, cool place. 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)	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.