Description

Dolutegravir Impurity 5 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 routine quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Dolutegravir API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities during the manufacturing process.
• Quality Control & Assurance: Serves as a system suitability and calibration standard in routine QC testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways and chemical behavior of Dolutegravir.

Basic Information

Product Name	Dolutegravir Impurity 5
CAS No.	1309575-43-6
Molecular Formula	C20H19F2N3O5
Molecular Weight	419.38 g/mol
Synonyms	Dolutegravir Related Compound 5; (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 Impurity F; GSK1349572 Impurity 5
EINECS	Contact for details

Quality Control

Every batch of Dolutegravir Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing purity by HPLC, related substances, residual solvents, and other critical parameters is provided with each shipment.

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.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
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.