Description

Bictegravir is a potent and selective integrase strand transfer inhibitor (INSTI) used in antiretroviral therapy. This high-purity active pharmaceutical ingredient (API) is critical for the formulation of modern, single-tablet regimens for the treatment of HIV-1 infection. It is essential for pharmaceutical manufacturers and research institutions developing next-generation antiviral therapeutics. The compound is supplied under stringent quality controls to ensure batch-to-batch consistency and regulatory compliance.

Application

• Pharmaceutical API: Primary use as the active ingredient in fixed-dose combination tablets for HIV treatment.
• Antiviral Drug Formulation: Formulation into combination therapies with other antiretrovirals like emtricitabine and tenofovir alafenamide.
• Clinical Research: Use in preclinical and clinical studies for evaluating new HIV treatment protocols and combination efficacies.
• Reference Standard: Serves as a high-purity analytical reference standard for quality control laboratories.
• Process Development: Used in R&D for optimizing synthesis pathways and developing generic formulations.

Basic Information

Product Name	Bictegravir
CAS No.	1611493-60-7
Molecular Formula	C₂₁H₁₈F₃N₃O₅
Molecular Weight	449.38 g/mol
Synonyms	Bictegravir; GS-9883; (2R,5S,13aR)-8-Hydroxy-7,9-dioxo-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazepine-10-carboxamide, N-[(2,4-Difluorophenyl)methyl]-6-(trifluoromethyl)-; Biktarvy component
EINECS	Contact for details

Quality Control

Our Bictegravir is manufactured under current Good Manufacturing Practice (cGMP) conditions to ensure the highest standards of purity and safety. Each batch is subjected to comprehensive analytical testing, including identity confirmation, assay, and impurity profiling via HPLC and related substances methods. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with in-house specifications aligned with major pharmacopoeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Total impurities ≤ 1.0%; Any single impurity ≤ 0.5%
Heavy Metals	≤ 20 ppm

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