Description

Raltegravir Oxalamide Impurity is a high-purity chemical reference standard used in the research, development, and quality control of the active pharmaceutical ingredient (API) Raltegravir. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by serving as a benchmark for impurity identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the production and validation of antiretroviral medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analytical method development and validation of Raltegravir API.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control the levels of this specific impurity, ensuring drug product purity meets pharmacopeial specifications (e.g., USP, EP).
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to characterize and establish acceptable limits for impurities in the drug substance.
• Stability Studies: Employed to identify and track the formation of this impurity during forced degradation and long-term stability testing of Raltegravir formulations.
• Research & Development (R&D): Utilized in synthetic chemistry research to study the formation pathway and develop purification processes to minimize this impurity.
• Contract Research Organizations (CROs): Used by analytical service providers to offer impurity profiling and method validation services to pharmaceutical clients.

Basic Information

Product Name	Raltegravir Oxalamide Impurity
CAS No.	1193687-86-3
Molecular Formula	C20H21FN6O5
Molecular Weight	444.42 g/mol
Synonyms	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; Raltegravir Oxalamide Related Compound; Raltegravir Impurity; Isentress Impurity; MK-0518 Impurity; Oxalamide Impurity of Raltegravir
EINECS	Contact for details

Quality Control

Our Raltegravir Oxalamide Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity analysis, residual solvent screening, and structural confirmation (NMR, MS), to ensure it meets the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) with detailed chromatographic data are provided for every lot to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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