Description

Elvitegravir Acyl Glucuronide is a key metabolite of the antiretroviral drug Elvitegravir, an integrase inhibitor used in HIV treatment. This reference standard is critical for pharmaceutical research and development, particularly in drug metabolism and pharmacokinetic (DMPK) studies to ensure safety and efficacy. It is an essential material for analytical laboratories, contract research organizations (CROs), and pharmaceutical companies engaged in bioanalytical method development, metabolite identification, and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the quantitative and qualitative analysis of Elvitegravir metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK): Crucial for in vitro and in vivo studies to understand the metabolic pathway, clearance, and exposure of Elvitegravir.
• Bioanalytical Method Development and Validation: Used to develop, calibrate, and validate LC-MS/MS and HPLC methods for accurate metabolite quantification in plasma, serum, and urine.
• Regulatory Submission and Compliance: Supports Investigational New Drug (IND) and New Drug Application (NDA) submissions to agencies like the FDA and EMA by providing definitive metabolite characterization data.
• Toxicology and Safety Assessment: Employed in studies to assess the potential toxicity and safety profile of drug metabolites.
• Clinical Research: Used in clinical trials to monitor patient metabolite levels, assess drug-drug interactions, and correlate exposure with therapeutic outcomes.

Basic Information

Product Name	Elvitegravir Acyl Glucuronide
CAS No.	870649-25-5
Molecular Formula	C25H24F2N3O8S
Molecular Weight	564.54 g/mol
Synonyms	Elvitegravir glucuronide; GS-9137 glucuronide; (3S,11aR)-6-Hydroxy-3-methyl-9-[(4-{[(prop-2-en-1-yloxy)carbonyl]amino}-1,3-thiazol-2-yl)methyl]-2,4-dioxo-1,3,4,6,11,11a-hexahydro-2H-pyrazino[1,2-b]isoquinolin-7-yl β-D-glucopyranosiduronic acid; Elvitegravir Acyl-β-D-Glucuronide; GS 9137 Acyl Glucuronide; Elvitegravir metabolite M4
EINECS	Contact for details

Quality Control

Our Elvitegravir Acyl Glucuronide is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and LC-MS for structural confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. Comprehensive Certificates of Analysis (COA) with detailed chromatographic data are provided to support your research and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry environment. This compound is hygroscopic (moisture-sensitive). Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake.

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)	Meets ICH guidelines

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