Description

Dolutegravir Impurity 6 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the quality control and regulatory compliance of Dolutegravir, a key antiretroviral medication. It is primarily used by analytical laboratories, quality assurance departments, and research scientists in the pharmaceutical industry for method validation, impurity profiling, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Dolutegravir Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels throughout the manufacturing process.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and demonstrate product safety.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and optimize manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Dolutegravir Impurity 6
CAS No.	1357289-29-2
Molecular Formula	C20H19F2N3O5
Molecular Weight	419.38 g/mol
Synonyms	(4R,12aS)-9-[(2,4-Difluorophenyl)methyl]-N-(2-hydroxy-3-methylbutyl)-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-7-carboxamide; Dolutegravir Related Compound 6; Dolutegravir Impurity F; S/GSK1349572 Impurity 6
EINECS	Contact for details

Quality Control

Our Dolutegravir Impurity 6 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS analyses. We adhere to relevant ICH Q3A/B guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.10% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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