Description

Raltegravir Diketo Ethoxy Impurity is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Raltegravir. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance, and regulatory affairs for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Raltegravir API and its formulations.
• Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing to ensure Raltegravir drug substances and products meet stringent pharmacopeial (USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity characterization and control strategies.
• Research & Development: Aids in synthetic route optimization and process chemistry by helping to understand and control the formation of this specific process-related impurity.

Basic Information

Product Name	Raltegravir Diketo Ethoxy Impurity
CAS No.	1193687-88-5
Molecular Formula	C20H20FN6O5
Molecular Weight	443.41 g/mol
Synonyms	Raltegravir Ethoxy Diketo Impurity; Raltegravir Related Compound; (4-Fluorobenzyl)-N-(2-ethoxy-1,2-dioxoethyl)-4-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidine-5-carboxamide; Isentress Impurity; MK-0518 Impurity; Raltegravir EP Impurity; Raltegravir USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Raltegravir Diketo Ethoxy Impurity is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the exacting standards of the pharmaceutical industry. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including HPLC purity, related substances, residual solvents, and identification (IR, MS). Specifications align with current pharmacopeial expectations and ICH Q3A/B 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). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. 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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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