Description

Dolutegravir Impurity 8 is a designated impurity of the active pharmaceutical ingredient (API) Dolutegravir, an integrase strand transfer inhibitor used in antiretroviral therapy. This reference standard is critical for analytical research and development, enabling the identification, quantification, and control of this specific impurity during drug manufacturing. It is an essential material for pharmaceutical companies, contract research organizations (CROs), and quality control laboratories focused on ensuring the purity, safety, and regulatory compliance of Dolutegravir-based drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of Dolutegravir Impurity 8 in API and finished dosage forms.
• Method Development and Validation: Used in the development, optimization, and validation of analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control & Assurance (QC/QA): Employed as a system suitability standard and for routine impurity profiling to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Stability Studies: Monitors the formation and level of this impurity under various stress conditions (e.g., heat, humidity, light) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Research & Development: Facilitates studies on impurity formation pathways, degradation chemistry, and process optimization during API synthesis.

Basic Information

Product Name	Dolutegravir Impurity 8
CAS No.	2244161-72-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dolutegravir Related Compound 8; Dolutegravir EP Impurity I; Dolutegravir Process Impurity; (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; S/GSK1349572 Impurity 8
EINECS	Contact for details

Quality Control

Every batch of Dolutegravir Impurity 8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure compliance with industry standards and customer specifications. A comprehensive Certificate of Analysis (COA), detailing batch-specific results from tests such as HPLC purity, related substances, and residual solvents, is provided and available upon request to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants under an inert atmosphere.

Specification

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

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