Description

Raltegravir Ep Impurity F is a high-purity chemical reference standard, specifically identified as a known impurity of the antiretroviral drug Raltegravir. This compound is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of impurities during drug substance manufacturing. It is an essential material for quality assurance laboratories in the pharmaceutical industry, particularly those involved in analytical method development, validation, and regulatory compliance for HIV treatment medications.

Application

• Primary use as a pharmaceutical reference standard for the analytical characterization of Raltegravir drug substance and finished products.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for impurity profiling.
• Used in stability studies to monitor the formation of degradation products under various stress conditions.
• Serves as a system suitability standard in quality control (QC) testing to ensure the reliability of chromatographic assays.
• Essential for meeting regulatory requirements (e.g., ICH Q3A(R2), Q3B(R2)) for identification and qualification of impurities in new drug applications (NDAs) and abbreviated new drug applications (ANDAs).
• Supports pharmacopoeial testing and compliance with monographs from USP (United States Pharmacopeia) and EP (European Pharmacopoeia).

Basic Information

Product Name	Raltegravir Ep Impurity F
CAS No.	2138805-56-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Raltegravir Related Compound F; Raltegravir Impurity F; (4-Fluorobenzyl)adenosine Derivative (Raltegravir-related); Isentress Impurity F; MK-0518 Impurity F; 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 Impurity
EINECS	Contact for details

Quality Control

Our Raltegravir Ep Impurity F is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS). We provide full traceability and Certificates of Analysis (COA) that detail batch-specific results. The material is suitable for use as a reference standard in regulated environments, supporting compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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