Description

Raltegravir Ep Impurity H is a specified impurity and degradation product of the antiretroviral drug Raltegravir, used in analytical research and pharmaceutical quality control. This high-purity reference standard is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Raltegravir API and finished dosage forms.
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) in quality control laboratories.
• Used in stability studies to monitor degradation pathways and establish shelf-life for Raltegravir-based products.
• Critical for regulatory compliance and filing, supporting applications to agencies like the FDA, EMA, and PMDA.
• Serves as a research tool in pharmacokinetic and metabolic studies to understand drug behavior.
• Employed in the calibration of analytical equipment to ensure accurate and reproducible results.

Basic Information

Product Name	Raltegravir Ep Impurity H
CAS No.	1391918-18-5
Molecular Formula	C20H19FN6O5
Molecular Weight	442.40 g/mol
Synonyms	Raltegravir Related Compound H; Raltegravir Impurity H; (4-Fluorobenzyl)-N-(2-hydroxy-1,3-dioxo-1,3-dihydro-2H-isoindol-4-yl)-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidine-4-carboxamide; Isomer of Raltegravir; Raltegravir Degradant H; Raltegravir Process Impurity H; Raltegravir EP Impurity H
EINECS	Contact for details

Quality Control

Our Raltegravir Ep Impurity H is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS). We provide a detailed Certificate of Analysis (COA) with each shipment, ensuring traceability and compliance with current pharmacopeial standards (EP, USP) and ICH guidelines. Our commitment is to supply reference materials of the highest consistency and reliability for critical pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider conditions 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 single 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.