Description

Dolutegravir Impurity 8 CAS NO 1916490-96-4 is a high-purity chemical 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

• Primary use as a certified reference standard for the identification and quantification of impurities in Dolutegravir API and finished drug products.
• Essential for pharmaceutical research and development (R&D), supporting the synthesis and purification process of Dolutegravir.
• Critical component in analytical method development and validation (e.g., HPLC, LC-MS) to meet ICH guidelines.
• Used in quality control (QC) and quality assurance (QA) laboratories for routine batch testing and stability studies.
• Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs).
• Valuable for academic and pharmacological studies investigating the properties and behavior of Dolutegravir-related substances.

Basic Information

Product Name	Dolutegravir Impurity 8
CAS No.	1916490-96-4
Molecular Formula	C20H19F2N3O5
Molecular Weight	419.38 g/mol
Synonyms	(4R,12aS)-9-[(2,4-Difluorophenyl)methyl]-N-(2-hydroxyethyl)-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 8; Dolutegravir EP Impurity H; Dolutegravir USP Impurity; GSK1349572 Impurity 8; S/GSK1349572 Impurity 8; Tivicay Impurity 8
EINECS	Contact for details

Quality Control

Our Dolutegravir Impurity 8 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical impurity analysis. Each batch undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. A Certificate of Analysis (COA) is provided with each shipment, detailing all test results and confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines. Our quality commitment supports your regulatory and compliance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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