Description

Raltegravir CAS NO 518048-05-0 is a potent and selective integrase strand transfer inhibitor (INSTI) used as an active pharmaceutical ingredient (API). It is a critical component in the treatment of HIV-1 infection, specifically designed to block the integration of viral DNA into the host genome. This high-purity compound is essential for pharmaceutical manufacturers and research institutions developing antiretroviral therapies and conducting virology studies.

Application

• Pharmaceutical API: Primary use as the active ingredient in antiretroviral medications for the treatment of HIV-1 infection.
• Fixed-Dose Combination Drugs: Formulation into combination therapies with other antiretroviral agents to improve patient compliance.
• Clinical Research: Use in clinical trials for evaluating new treatment regimens, dosage forms, or pediatric formulations.
• Virology & Drug Discovery: Serves as a reference standard and tool compound in research focused on HIV integrase mechanisms and resistance profiling.
• Generic Drug Manufacturing: Production of bioequivalent generic versions of branded antiretroviral drugs containing Raltegravir.
• Analytical Standard: Utilized as a high-purity standard for quality control (QC) and analytical method development in pharmaceutical laboratories.

Basic Information

Product Name	Raltegravir
CAS No.	518048-05-0
Molecular Formula	C20H21FN6O5
Molecular Weight	444.42 g/mol
Synonyms	MK-0518; Isentress (Brand Name); 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; Raltegravir Potassium; Raltegravirum; (4-Fluorobenzyl)-N-(1-methyl-1-{[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino}ethyl)-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidine-4-carboxamide
EINECS	Contact for details

Quality Control

Our Raltegravir is manufactured under strict quality systems to meet the rigorous standards required for pharmaceutical applications. Each batch is tested to ensure compliance with relevant pharmacopeial monographs (e.g., USP, EP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles is provided with every shipment to guarantee traceability and batch-to-batch consistency.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Microbial Enumeration	Meets Ph. Eur. 2.6.12 / USP <61>

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