Description

Dolutegravir Impurity 3 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, a key antiretroviral medication. 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 drug products.
• Analytical Method Development: Essential for developing and validating chromatographic methods (HPLC, UPLC) to monitor impurity profiles during API synthesis.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine batch release testing to ensure product purity meets pharmacopeial limits.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation and level of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Research & Development (R&D): Used in synthetic chemistry research to study impurity formation pathways and to develop improved purification processes for the API.

Basic Information

Product Name	Dolutegravir Impurity 3
CAS No.	1973402-05-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dolutegravir Related Compound 3; Dolutegravir Impurity C; (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 C; Dolutegravir USP Impurity 3; Tivicay Impurity 3
EINECS	Contact for details

Quality Control

Our Dolutegravir Impurity 3 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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