Description

Baloxavir is a potent and selective cap-dependent endonuclease inhibitor, representing a significant advancement in antiviral therapy. Its primary value lies in its novel mechanism of action, which targets the influenza virus polymerase complex to inhibit viral replication effectively. This active pharmaceutical ingredient (API) is essential for pharmaceutical manufacturers and research institutions developing next-generation antiviral treatments for influenza A and B viruses.

Application

• Pharmaceutical API: Primary active ingredient in the formulation of oral antiviral medications for the treatment of acute, uncomplicated influenza.
• Clinical Research: Used in preclinical and clinical studies to investigate efficacy, pharmacokinetics, and new therapeutic regimens against influenza strains.
• Antiviral Drug Development: Serves as a key reference standard and building block in the R&D of novel anti-influenza compounds and combination therapies.
• Dosage Form Manufacturing: Incorporated into the production of solid oral dosage forms, such as tablets and granules, under current Good Manufacturing Practice (cGMP) standards.

Basic Information

Product Name	Baloxavir
CAS No.	1985605-59-1
Molecular Formula	C₂₇H₂₃F₂N₃O₄S
Molecular Weight	523.55 g/mol
Synonyms	Baloxavir marboxil (prodrug); S-033188; Xofluza (brand name); (12aS)-N-[(11S)-7,8-Difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-12-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; Cap-dependent endonuclease inhibitor; BXM
EINECS	Contact for details

Quality Control

Our Baloxavir is manufactured and tested to meet stringent pharmaceutical-grade specifications. Quality is assured through a comprehensive analytical program including HPLC for purity, residual solvent analysis, and stringent control of related substances. A Certificate of Analysis (COA) is provided with each batch, detailing compliance with in-house specifications aligned with ICH guidelines. We support development and commercial projects requiring material produced under current Good Manufacturing Practice (cGMP) 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, which may affect stability and performance. For long-term storage, consider desiccants or inert atmosphere.

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)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5%; Any single unknown impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤0.5%
Heavy Metals	≤20 ppm

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