Description

Bictegravir Sodium is the sodium salt form of bictegravir, a potent and selective integrase strand transfer inhibitor (INSTI). This high-purity active pharmaceutical ingredient (API) is critical for the formulation of next-generation antiretroviral therapies. It is primarily utilized by pharmaceutical manufacturers and research institutions engaged in the development and production of fixed-dose combination treatments for HIV-1 infection.

Application

• Pharmaceutical API: Core component in the synthesis of antiretroviral drug products for the treatment of HIV-1.
• Fixed-Dose Combination (FDC) Tablets: Used in the manufacture of single-tablet regimens (STRs) for improved patient compliance.
• Research & Development: Serves as a reference standard and key intermediate in preclinical and clinical studies for novel HIV therapeutics.
• Formulation Development: Employed in the development of various oral dosage forms, including tablets and capsules.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for commercial-scale pharmaceutical production.

Basic Information

Product Name	Bictegravir Sodium
CAS No.	1807988-02-8
Molecular Formula	C21H17F3N3NaO5
Molecular Weight	471.36 g/mol
Synonyms	Bictegravir Sodium Salt; Bictegravir Na; GS-9883 Sodium; (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, Sodium Salt; Sodium (2R,5S,13aR)-10-(aminocarbonyl)-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]oxazepin-4-olate; BIC Sodium; Biktarvy Component Sodium Salt
EINECS	Contact for details

Quality Control

Our Bictegravir Sodium is manufactured under strict quality management systems. Each batch is tested to ensure it meets high-purity standards suitable for pharmaceutical use, with typical purity exceeding 99.0% (by HPLC). Certificates of Analysis (COA) are provided, detailing results for identity, assay, related substances, residual solvents, and other critical parameters. We support compliance with ICH Q7 guidelines and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥ 99.0%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single unknown impurity ≤ 0.10%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH Q3C limits
Heavy Metals	≤ 20 ppm

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