Description

Dolutegravir Sodium is the sodium salt form of dolutegravir, a potent and selective integrase strand transfer inhibitor (INSTI). This active pharmaceutical ingredient (API) is a critical component in the formulation of antiretroviral medications used to manage HIV-1 infection. It is essential for pharmaceutical manufacturers and research institutions developing next-generation HIV therapies. The compound is recognized for its high barrier to resistance and is a cornerstone in modern combination antiretroviral regimens.

Application

• Pharmaceutical API: Primary use as the active ingredient in oral solid dosage forms (tablets) for the treatment of HIV-1 infection in adults and pediatric patients.
• Fixed-Dose Combination (FDC) Drugs: A key component in combination tablets with other antiretroviral agents like abacavir and lamivudine.
• Research & Development: Used in preclinical and clinical studies for investigating new HIV treatment protocols and drug delivery systems.
• Generic Drug Manufacturing: Sourcing for the production of bioequivalent generic versions of branded dolutegravir-containing medications.
• Analytical Reference Standard: Serves as a high-purity standard in quality control laboratories for HPLC, dissolution testing, and method validation.

Basic Information

Product Name	Dolutegravir Sodium
CAS No.	1051375-19-9
Molecular Formula	C20H18F2N3NaO5
Molecular Weight	441.36 g/mol
Synonyms	Dolutegravir Sodium Salt; S/GSK1349572 Sodium; (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 Sodium Salt; GSK1349572 Sodium; Tivicay (API form); DTG Sodium; Integrase Inhibitor DTG Sodium; Bictegravir Intermediate (related compound)
EINECS	Contact for details

Quality Control

Our Dolutegravir Sodium is manufactured under strict quality management systems. Each batch is tested to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with every shipment, detailing results for assay, related substances, residual solvents, and microbiological limits. We support compliance with cGMP, FDA, and EMA regulatory requirements for pharmaceutical ingredients.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.15% Total impurities: NMT 0.5%
Water Content (KF)	NMT 5.0%
Residual Solvents (GC)	Complies with ICH Q3C Class 2 & 3 limits
Heavy Metals	NMT 20 ppm
Microbiological Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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