Description

Baloxavir Marboxil is a prodrug of baloxavir acid, a potent and selective inhibitor of the cap-dependent endonuclease enzyme essential for influenza virus replication. This mechanism offers a significant therapeutic advantage by targeting a different stage of the viral life cycle compared to neuraminidase inhibitors. It is a critical active pharmaceutical ingredient (API) primarily required by pharmaceutical manufacturers for the formulation of antiviral medications designed to treat acute, uncomplicated influenza in patients meeting specific clinical criteria.

Application

• Pharmaceutical API: Primary use as the active ingredient in antiviral tablet formulations.
• Influenza Treatment: Manufacture of prescription drugs for treating influenza A and B virus infections.
• Clinical Research: Serves as a reference standard and key material in virology and antiviral drug development studies.
• Drug Product Development: Used in R&D for developing new dosage forms and combination therapies.
• Generic Drug Manufacturing: Essential for companies producing generic versions of approved baloxavir marboxil-based medications.

Basic Information

Product Name	Baloxavir Marboxil
CAS No.	1985606-14-1
Molecular Formula	C₂₇H₂₃F₂N₃O₇S
Molecular Weight	571.55 g/mol
Synonyms	S-033188; S 033188; Baloxavir marboxil; Xofluza (brand name API); (12aR)-12-[(11S)-7,8-Difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-6,8-dioxo-3,4,6,8,12,12a-hexahydro-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazine-7-carboxylic acid methyl ester; BXM
EINECS	Contact for details

Quality Control

Our Baloxavir Marboxil is manufactured under strict quality management systems. It undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical use, including stringent control of related substances and residual solvents. A Certificate of Analysis (COA) detailing specifications such as assay, impurities, and identification is provided with each batch to ensure traceability and compliance with cGMP guidelines.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 1.5%
Water Content (KF)	NMT 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 20 ppm

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