Description

Raltegravir Usp Rc E CAS NO 1193687-87-4 is a high-purity reference standard material, specifically the E-isomer of Raltegravir, meeting the stringent quality requirements of the United States Pharmacopeia (USP). This compound is critical for analytical and quality control laboratories in the pharmaceutical industry, ensuring the accuracy and reliability of testing for the active pharmaceutical ingredient. It is primarily used by manufacturers, contract research organizations (CROs), and regulatory bodies involved in the development, production, and validation of antiretroviral medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification, assay, and impurity profiling of Raltegravir in drug substances and products.
• Analytical Method Development & Validation: Essential for developing, qualifying, and validating chromatographic (e.g., HPLC, UPLC) and spectroscopic analytical methods in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Used in-house by pharmaceutical manufacturers for routine batch release testing and stability studies to ensure product consistency and efficacy.
• Regulatory Submissions: Supports regulatory filings (e.g., to FDA, EMA) by providing definitive proof of the chemical identity and purity of the API used in clinical trials and commercial products.
• Pharmacopeial Testing: Direct application in conducting tests as prescribed in the USP monograph for Raltegravir to verify compliance.
• Research & Development: Serves as a high-purity benchmark in non-clinical R&D for studying drug metabolism, pharmacokinetics, and formulation development.

Basic Information

Product Name	Raltegravir Usp Rc E
CAS No.	1193687-87-4
Molecular Formula	C20H21FN6O5
Molecular Weight	444.42 g/mol
Synonyms	Raltegravir E-isomer; Raltegravir Impurity E; (4R,12aS)-N-(2-(4-(fluorobenzylcarbamoyl)-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidin-2-yl)propan-2-yl)-7-methyl-4,6-dioxo-3,4,6,12-tetrahydro-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide; Isentress Impurity E; MK-0518 Impurity E; Raltegravir Related Compound E
EINECS	Contact for details

Quality Control

This product is manufactured and controlled as a USP Reference Standard, ensuring it meets the highest benchmarks for identity, purity, and strength. Every batch undergoes rigorous analytical testing including HPLC for assay and related substances, residual solvent analysis, and comprehensive spectroscopic identification (IR, NMR, MS). A comprehensive Certificate of Analysis (COA) detailing all test results against specification is provided with each shipment to guarantee traceability and compliance for your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture uptake, which could affect stability and analytical performance.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with USP/ICH limits

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