Description

Dolutegravir o-β-D-Glucuronide Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Dolutegravir, a key antiretroviral medication. It serves as an essential tool for pharmaceutical manufacturers and analytical laboratories engaged in method development, validation, and regulatory compliance. The impurity is vital for impurity profiling, stability studies, and batch release testing in the production of HIV treatments.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Dolutegravir API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to detect and quantify this specific glucuronide metabolite impurity.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Used to monitor the formation of degradation products in Dolutegravir under various stress conditions (e.g., heat, humidity, light) as per ICH guidelines.
• Metabolism and Pharmacokinetic Research: Serves as a standard in studies investigating the metabolic pathways, pharmacokinetics, and bioavailability of Dolutegravir.
• Contract Research & Testing Laboratories (CROs/CTLs): Essential for third-party labs providing analytical testing services to the pharmaceutical industry.

Basic Information

Product Name	Dolutegravir o-β-D-Glucuronide Impurity
CAS No.	1485692-21-4
Molecular Formula	C27H28N3O12
Molecular Weight	586.52 g/mol
Synonyms	Dolutegravir Glucuronide; Dolutegravir O-Glucuronide; (4R,12aS)-N-[(2,4-Difluorophenyl)methyl]-3,4,6,8,12,12a-hexahydro-7-hydroxy-4-methyl-6,8-dioxo-3-[[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)-2-tetrahydropyranyl]oxy]-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide; Dolutegravir Metabolite; Dolutegravir Impurity G (Potential Designation); GSK1349572 Glucuronide; S/GSK1349572 O-Glucuronide
EINECS	Contact for details

Quality Control

Every batch of Dolutegravir o-β-D-Glucuronide Impurity is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles to support our clients' regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This compound is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
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.