Description

Raltegravir Ep Impurity C is a specified impurity associated with the active pharmaceutical ingredient Raltegravir, an antiretroviral medication. This compound is critical for analytical reference and quality control in pharmaceutical development and manufacturing to ensure drug safety and efficacy. It is primarily required by pharmaceutical companies, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling. The availability of a well-characterized reference standard is essential for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of Raltegravir-related impurities in drug substances and products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection.
• Quality Control & Batch Release Testing: Employed in routine QC testing of Raltegravir API and finished dosage forms to monitor impurity levels against ICH guidelines.
• Stability Studies: A key component in forced degradation and long-term stability studies to track impurity formation over time.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in R&D to understand degradation pathways and synthesis processes of Raltegravir.

Basic Information

Product Name	Raltegravir Ep Impurity C
CAS No.	1391918-17-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Raltegravir Impurity C; Raltegravir Related Compound C; Isentress Impurity C; (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; 1,6-Dihydro-5-hydroxy-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-N,4-bis[(4-fluorophenyl)methyl]-4-pyrimidinecarboxamide
EINECS	Contact for details

Quality Control

Our Raltegravir Ep Impurity C is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and identity. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for purity, related substances, and identification. Our quality commitment aligns with ICH Q3A/B guidelines and supports compliance with cGMP standards for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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