Description

Dolutegravir Impurity 7 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Dolutegravir, an integrase strand transfer inhibitor. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Dolutegravir API and finished drug products.
• Analytical Method Development and Validation in quality control (QC) and research & development (R&D) laboratories.
• Stability Studies to monitor impurity formation under various stress conditions.
• Regulatory Compliance and Documentation, supporting filings with agencies like the FDA and EMA.
• Chemical Research into the degradation pathways and metabolism of Dolutegravir.
• Calibration of Analytical Instruments such as High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS).

Basic Information

Product Name	Dolutegravir Impurity 7
CAS No.	2244161-71-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dolutegravir Related Compound 7; Dolutegravir Impurity C; (4R,12aS)-N-(2,4-Difluorobenzyl)-7-hydroxy-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide; Dolutegravir EP Impurity C; Dolutegravir USP Impurity C; S/GSK1349572 Impurity 7
EINECS	Contact for details

Quality Control

Our Dolutegravir Impurity 7 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and traceability. A comprehensive Certificate of Analysis (COA) is provided with every shipment, detailing all test results and confirming compliance with in-house specifications suitable for use as a reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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