Description

Dolutegravir 4-Desfluoro Impurity (CAS No. 1863916-87-3) is a key process-related impurity and analytical reference standard used in the quality control of the active pharmaceutical ingredient (API) Dolutegravir. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of the desfluoro variant during manufacturing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and production of HIV-1 integrase strand transfer inhibitor therapies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of the 4-desfluoro variant in Dolutegravir API and finished dosage forms.
• Method Development & Validation: Essential for developing and validating robust analytical methods (e.g., HPLC, UPLC, LC-MS) to monitor process impurities.
• Quality Control & Assurance: Used in routine batch release testing to ensure Dolutegravir API meets stringent pharmacopeial (USP, EP) and ICH Q3A/B guidelines for impurity profiles.
• Regulatory Compliance & Filings: Critical for preparing regulatory submission documents (e.g., CMC sections for FDA, EMA) to demonstrate comprehensive impurity control.
• Process Chemistry Research: Employed in research to study the formation and fate of this impurity during the synthesis and purification of Dolutegravir.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies to track impurity levels over time.

Basic Information

Product Name	Dolutegravir 4-Desfluoro Impurity
CAS No.	1863916-87-3
Molecular Formula	C20H18F2N3O5
Molecular Weight	418.37 g/mol
Synonyms	4-Desfluoro Dolutegravir; Dolutegravir 4-Desfluoro Analog; (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 Impurity 4; Dolutegravir Related Compound 4; Tivicay Impurity 4; GSK1349572 4-Desfluoro Impurity
EINECS	Contact for details

Quality Control

Our Dolutegravir 4-Desfluoro Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure high purity and identity confirmation, aligning with ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided, detailing results from tests including HPLC purity, identity (IR, MS), and residual solvent analysis. We support compliance with cGMP standards for pharmaceutical impurities and reference materials.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.