Description

Dolutegravir Impurity C is a specified, high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Dolutegravir, an integrase strand transfer inhibitor. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical companies, contract research organizations (CROs), and regulatory testing laboratories.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification, qualification, and quantification of impurities in Dolutegravir API and finished drug products.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and UPLC, in compliance with ICH Q2(R1) guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity profiles and ensure batches meet stringent pharmacopeial (USP, EP) and internal specification limits.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (forced degradation studies) to establish product shelf life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Supports synthetic route optimization and process chemistry research by helping to identify and control process-related impurities.

Basic Information

Product Name	Dolutegravir Impurity C
CAS No.	1802141-49-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dolutegravir Related Compound 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 Impurity; Dolutegravir EP Impurity C; Dolutegravir USP Impurity C; S/GSK1349572 Impurity C; Tivicay Impurity C
EINECS	Contact for details

Quality Control

Our Dolutegravir Impurity C is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

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%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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