Description

Raltegravir USP Impurity C is a high-purity chemical reference standard, specifically identified as an impurity of the active pharmaceutical ingredient Raltegravir. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing, ensuring drug safety and regulatory compliance. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in the development and production of HIV-1 integrase inhibitor medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Raltegravir USP Impurity C in drug substances and products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity levels and ensure adherence to pharmacopeial specifications (USP, ICH guidelines).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug approval dossiers.
• Stability Studies: Used to track the formation and level of this specific impurity under various stability-indicating conditions.
• Research & Development: Facilitates research into the degradation pathways and chemical behavior of Raltegravir during formulation and storage.

Basic Information

Product Name	Raltegravir USP Impurity C
CAS No.	1193687-85-2
Molecular Formula	C20H19FN6O5
Molecular Weight	442.40 g/mol
Synonyms	Raltegravir Impurity C; Raltegravir Related Compound C; (4-Fluorobenzyl)-N-{2-[4-(4-fluorobenzylcarbamoyl)-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidin-2-yl]propan-2-yl}-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidine-4-carboxamide; Isentress Impurity C; MK-0518 Impurity C; Raltegravir EP Impurity C
EINECS	Contact for details

Quality Control

Every batch of Raltegravir USP Impurity C is manufactured and controlled under strict quality management systems. The product is characterized and tested to meet high-purity standards suitable for use as a pharmaceutical reference standard. Comprehensive analytical testing, including HPLC for purity and spectroscopic methods for structural confirmation, is performed. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The material is light-sensitive (store away from light) and hygroscopic (moisture-sensitive).

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%
Residue on Ignition	≤ 0.1%

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