Description

Raltegravir Ep Impurity D CAS NO 1064706-98-4 is a specified impurity of the antiretroviral drug Raltegravir, used for analytical reference and quality control purposes. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product in compliance with stringent regulatory standards. It is primarily used in the research, development, and quality assurance processes for HIV treatment medications.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Raltegravir active pharmaceutical ingredient (API) and finished dosage forms.
• Essential for method development and validation in analytical laboratories using techniques like HPLC, UPLC, and LC-MS.
• Critical component in stability studies and forced degradation studies to monitor impurity profiles over time.
• Used for regulatory compliance and filing, supporting applications to agencies like the FDA, EMA, and other global health authorities.
• Serves as a calibration standard in quality control (QC) laboratories to ensure batch-to-batch consistency.
• Valuable for research and development of new synthetic routes and purification processes for Raltegravir.

Basic Information

Product Name	Raltegravir Ep Impurity D
CAS No.	1064706-98-4
Molecular Formula	C20H19F2N3O5
Molecular Weight	419.38 g/mol
Synonyms	Raltegravir Related Compound D; Raltegravir Impurity D; (4-Fluorobenzyl)-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; Isentress Impurity D; MK-0518 Impurity D; Raltegravir EP Impurity D; Raltegravir USP Impurity D
EINECS	Contact for details

Quality Control

Our Raltegravir Ep Impurity D is manufactured under strict quality systems to meet the exacting standards of the pharmaceutical industry. Each batch is characterized and tested using advanced analytical techniques to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, including HPLC purity and related substance profiles, traceable to primary reference standards. The material is suitable for use in methods aligned with EP (European Pharmacopoeia), USP (United States Pharmacopeia), and ICH 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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

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

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