Description

Dolutegravir 2-Desfluoro Impurity is a key process-related impurity and a critical reference standard in the synthesis and quality control of the active pharmaceutical ingredient (API) Dolutegravir. This compound is essential for pharmaceutical manufacturers to ensure the purity, safety, and regulatory compliance of their final drug products. It is primarily used by analytical laboratories, R&D facilities, and quality control units within the global pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of the 2-desfluoro impurity in Dolutegravir API and finished dosage forms.
• Method Development & Validation: Critical for developing and validating robust analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control & Assurance: Used in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and demonstrate control strategies.
• Process Chemistry Research: Aids in understanding the synthesis pathway of Dolutegravir and optimizing manufacturing processes to minimize this impurity.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to assess the degradation profile of Dolutegravir formulations.

Basic Information

Product Name	Dolutegravir 2-Desfluoro Impurity
CAS No.	1863916-88-4
Molecular Formula	C20H18F2N3O5
Molecular Weight	418.37 g/mol
Synonyms	2-Desfluoro Dolutegravir; Dolutegravir 2-Desfluoro Analog; Dolutegravir Impurity 2; (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 Related Compound 2; Tivicay Impurity 2; GSK1349572 2-Desfluoro Impurity
EINECS	Contact for details

Quality Control

Every batch of Dolutegravir 2-Desfluoro Impurity is manufactured under a strict quality management system and undergoes comprehensive analytical characterization to ensure identity, purity, and consistency. Our quality control protocols are designed to meet the stringent requirements of pharmaceutical reference standards, with testing typically including HPLC purity, NMR, and MS for structural confirmation. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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