Description

Raltegravir Diketo Methoxy Impurity is a designated process-related impurity and reference standard used in the pharmaceutical development and quality control of Raltegravir, an antiretroviral medication. This compound is critical for ensuring the purity, safety, and efficacy of the final Active Pharmaceutical Ingredient (API) by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, validation, and batch release of Raltegravir.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Raltegravir API.
• Critical component in analytical method development and validation (HPLC, LC-MS) for Raltegravir.
• Essential for stability studies and impurity profiling to meet ICH Q3A/B guidelines.
• Used in regulatory submissions (e.g., to FDA, EMA) to establish impurity limits and control strategies.
• Supports process chemistry research to optimize synthesis pathways and minimize impurity formation.
• Employed in quality control laboratories for routine batch analysis and release testing of Raltegravir.

Basic Information

Product Name	Raltegravir Diketo Methoxy Impurity
CAS No.	518048-04-9
Molecular Formula	C20H19FN6O5
Molecular Weight	442.40 g/mol
Synonyms	Raltegravir Impurity; Raltegravir Related Compound; (4-Fluorobenzyl)-N-(2-(5-(methoxycarbonyl)-4-oxo-3,4-dihydro-1H-pyrazolo[3,4-b]pyridin-1-yl)-2-oxoethyl)-1,3,4-oxadiazole-2-carboxamide; Isentress Impurity; MK-0518 Impurity; Diketo Methoxy Impurity of Raltegravir; 1H-Pyrazolo[3,4-b]pyridine-5-carboxylic acid, 4-oxo-1-[2-[[(4-fluorophenyl)methyl]amino]-2-oxoethyl]-3,4-dihydro-, methyl ester
EINECS	Contact for details

Quality Control

This high-purity reference material is manufactured and tested under strict quality management systems. Each batch is characterized using advanced spectroscopic and chromatographic techniques to confirm identity and purity, ensuring compliance with ICH guidelines and relevant pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical methods (e.g., HPLC, NMR) is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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