Description

Dolutegravir Impurity 6 CAS NO 1809261-48-0 is a specified, structurally characterized impurity used in the quality control of the active pharmaceutical ingredient (API) Dolutegravir. This high-purity reference standard is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is an essential material for pharmaceutical R&D laboratories, quality assurance/control (QA/QC) units, and manufacturers involved in the production and analysis of Dolutegravir and its formulations.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Dolutegravir API.
• Critical component in method development and validation for analytical techniques like HPLC and UPLC.
• Essential for stability studies and forced degradation studies to understand the degradation pathways of Dolutegravir.
• Used in regulatory submissions (e.g., for FDA, EMA) to establish impurity profiles and specifications.
• Supports pharmaceutical research into the synthesis, metabolism, and pharmacokinetics of Dolutegravir.
• Quality control tool for batch release testing of Dolutegravir drug substances and products.

Basic Information

Product Name	Dolutegravir Impurity 6
CAS No.	1809261-48-0
Molecular Formula	C20H19F2N3O5
Molecular Weight	419.38 g/mol
Synonyms	Dolutegravir Related Compound 6; (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 F; Dolutegravir USP Impurity F; Dolutegravir Process Impurity; Tivicay 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 purity by HPLC, related substance profile, and other critical parameters. Our quality commitment aligns with the standards required for pharmaceutical reference materials, supporting compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing desiccated at -20°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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