Description

Raltegravir -D-Glucuronide is a high-purity metabolite reference standard of the antiretroviral drug Raltegravir. This compound is critical for pharmaceutical research and development, particularly in the study of drug metabolism and pharmacokinetics (DMPK). It is primarily utilized by analytical laboratories and pharmaceutical companies engaged in bioanalytical method development, metabolite identification, and regulatory compliance testing for antiretroviral therapies.

Application

• Bioanalytical Reference Standard: Serves as a certified standard for the quantitative and qualitative analysis of Raltegravir metabolites in biological matrices (e.g., plasma, urine) using LC-MS/MS or HPLC.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Essential for investigating the metabolic pathways, clearance mechanisms, and pharmacokinetic profile of Raltegravir.
• Pharmaceutical Impurity Profiling: Used to identify, characterize, and quantify glucuronidated impurities or degradation products in drug substance and finished product stability studies.
• Clinical Research Support: Supports clinical trial studies by enabling accurate measurement of metabolite levels to assess efficacy and safety.
• Regulatory Submission: Provides essential data for regulatory filings (e.g., FDA, EMA) requiring comprehensive metabolite characterization and safety assessment.
• In-vitro Metabolism Studies: Used in incubation studies with hepatocytes or microsomal fractions to elucidate phase II conjugation metabolism.

Basic Information

Product Name	Raltegravir -D-Glucuronide
CAS No.	952654-62-5
Molecular Formula	C26H30N6O12
Molecular Weight	594.55 g/mol
Synonyms	Raltegravir D-Glucuronide; Raltegravir Glucuronide; Raltegravir β-D-Glucuronide; (2S,3R,4S,5S,6S)-6-[[(1S)-4-[(4-Fluorobenzyl)carbamoyl]-1-hydroxy-2-oxo-1,2-dihydro-1,5-naphthyridin-3-yl]oxy]-3,4,5-trihydroxyoxane-2-carboxylic Acid; Isentress Metabolite; MK-0518 Glucuronide; N-[(4-Fluorophenyl)methyl]-1,6-dihydro-5-hydroxy-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-4-pyrimidinecarboxamide Glucuronide
EINECS	Contact for details

Quality Control

Our Raltegravir -D-Glucuronide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, LC-MS identity confirmation, and residual solvent analysis, to ensure compliance with high-purity reference standard requirements. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and regulatory support.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below for long-term stability. For short-term use, the material may be stored at 2-8°C. Allow the vial to equilibrate to room temperature in a desiccator before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH guidelines

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