Baloxavir Marboxil USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Baloxavir Marboxil USP/EP

High-purity pharmaceutical grade Baloxavir Marboxil manufactured under stringent cGMP conditions. This cap-dependent endonuclease inhibitor API is essential for influenza treatment, providing reliable quality and regulatory compliance for modern antiviral therapeutics.

  • USP/EP Grade Pharmaceutical API
  • cGMP Manufacturing Standards
  • ≥99.0% Purity (HPLC)
  • Comprehensive COA Documentation
  • Cap-dependent Endonuclease Inhibitor
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: C27H23F2N3O7S
CAS Number: 1985606-14-1
Molecular Weight: 571.55 g/mol
Purity (HPLC): ≥99.0% (pharmaceutical grade)
Physical State: White to off-white crystalline powder
Water Content (Karl Fischer): ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% total impurities
Storage Conditions: Store in cool, dry place (15-30°C)
Packaging Options: 1kg, 5kg pharmaceutical containers

Applications

Antiviral Drug Manufacturing
Influenza Treatment Formulations
Oral Pharmaceutical Products
API Synthesis & Development
Cap-dependent Endonuclease Inhibitor Research
Pharmaceutical Research
Drug Product Manufacturing
Quality Control Testing
Regulatory Compliance
Clinical Trial Materials
Bioanalytical Method Development
Reference Standard Applications

Industry-Specific Grades

DRAVYOM offers specialized Baloxavir Marboxil grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse antiviral drug manufacturing applications.

USP Grade (Pharmaceutical)
Purity: ≥99.0% (HPLC) Water Content: ≤0.5% Heavy Metals: ≤10 ppm Application: Pharmaceutical formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% (pharmaceutical) Related Substances: ≤1.0% Residue on Ignition: ≤0.1% Application: European market compliance
Research Grade
Purity: ≥98.0% (analytical) Water Content: ≤1.0% Particle Size: Controlled Application: R&D, method development
GMP Grade
Purity: ≥99.5% (pharmaceutical) Endotoxins: ≤2.5 EU/mg Microbial Limits: Compliant Application: Antiviral formulations

Quality Standards

DRAVYOM's pharmaceutical grade Baloxavir Marboxil is manufactured under stringent cGMP protocols, meeting international pharmaceutical standards including USP, EP, and ICH guidelines. Our pharmaceutical-grade production ensures consistent quality and regulatory compliance.

cGMP Certified Manufacturing
USP/EP Grade Specifications
≥99.0% Pharmaceutical Purity
Advanced Analytical Testing
Comprehensive Impurity Control
Batch-to-Batch Consistency
Complete Documentation Package
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Pharmaceutical grade Baloxavir Marboxil exhibits exceptional chemical properties essential for antiviral applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and research applications.

Analytical Properties
Solubility (Water): Slightly soluble
LogP (octanol/water): 4.2
pKa: 3.8 ± 0.2
UV λmax: 278 nm
Physical Properties
Melting Point: 185-190°C
Bulk Density: 0.6-0.8 g/mL
Crystalline Form: White to off-white crystalline powder
Hygroscopicity: Non-hygroscopic
Pharmaceutical Performance
Bioavailability: 85-90%
Protein Binding: 93-96%
Half-life: 79-109 hours
Elimination: Primarily fecal (80%)
Purity Specifications
Assay (HPLC): ≥99.0%
Related Substances: ≤1.0% total
Water Content: ≤0.5% (Karl Fischer)
Residue on Ignition: ≤0.1%
Stability Properties
Shelf Life: 3 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Stable 2-8°C
Container Compatibility: HDPE, glass containers

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Baloxavir Marboxil superiority in antiviral applications with exceptional efficacy, bioavailability, and reproducibility across diverse pharmaceutical formulations and clinical protocols.

Antiviral Efficacy

IC50: 1.4-9.8 nM against influenza A/B

Potent cap-dependent endonuclease inhibition
Formulation Stability

Stable in solid dosage forms for 36 months

Excellent pharmaceutical stability
Bioavailability

85-90% oral bioavailability achieved

Superior absorption characteristics
Temperature Stability

Stable under pharmaceutical storage conditions

Consistent performance across temperatures
Batch Reproducibility

Variation: ±0.5% between batches

Exceptional lot-to-lot consistency
Shelf Stability

3 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Handle with standard pharmaceutical safety precautions. Use appropriate personal protective equipment including safety goggles, gloves, and protective clothing. Avoid inhalation of powder and ensure adequate ventilation in work areas. Follow established pharmaceutical handling protocols.

Caution
Avoid Inhalation
Wear Gloves

Storage & Handling

Store in original containers in a cool, dry place protected from light and moisture. Keep containers tightly closed and maintain pharmaceutical storage conditions. Use appropriate handling equipment and ensure controlled temperature environment.

Store at 2-8°C (refrigerated)
Protect from light
Protect from moisture
Keep containers tightly closed

Chemical Mechanisms & Reaction Pathways

Baloxavir Marboxil exhibits antiviral properties through cap-dependent endonuclease inhibition, enabling precise influenza treatment applications with predictable viral replication suppression pathways and quantitative therapeutic enhancement mechanisms.

Endonuclease Inhibition

Selective binding to PA endonuclease domain of viral polymerase

Quantitative viral RNA synthesis blockade
Prodrug Activation

Hydrolysis to active baloxavir acid metabolite

Essential for antiviral therapeutic activity
Viral Selectivity

Specific inhibition of influenza A and B viral strains

Enables targeted antiviral efficacy
Metal Coordination

Chelation of metal ions in viral endonuclease active site

Predictable pharmaceutical inhibition mechanism

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical access with complete documentation packages supporting international standards and pharmaceutical manufacturing validations.

USP Specifications

United States Pharmacopeia pharmaceutical standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical analysis

ICH Guidelines

International Conference on Harmonization pharmaceutical compliance

FDA Registration

United States Food and Drug Administration compliance

Method Validation

Supported analytical method validation documentation

SDS Documentation

Multi-language Safety Data Sheets (16 sections, GHS compliant)

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, stability testing assistance, and regulatory services to optimize pharmaceutical grade Baloxavir Marboxil performance in your specific therapeutic applications.

Formulation Development
  • Pharmaceutical formulation optimization support
  • Stability testing guidance
  • Bioavailability and bioequivalence validation
  • Custom pharmaceutical procedures
Analytical Services
  • Certificate of Analysis verification
  • Custom purity analysis
  • Impurity profiling and identification
  • Method validation support
Technical Support
  • Pharmaceutical troubleshooting consultation
  • Storage and handling guidance
  • Safety training and protocols
  • Manufacturing best practices
Supply Solutions
  • Consistent batch scheduling
  • Emergency supply arrangements
  • Custom packaging options
  • Global distribution network

Environmental Impact & Sustainability

Our pharmaceutical grade Baloxavir Marboxil production emphasizes environmental responsibility through sustainable manufacturing practices, waste minimization, and comprehensive environmental impact management for pharmaceutical operations.

Waste Minimization

Optimized production with minimal waste generation

Water Treatment

Advanced wastewater treatment and recycling systems

Clean Production

Energy-efficient synthesis with emission controls

Safe Disposal

Comprehensive guidance for pharmaceutical waste management

ISO 14001

Environmental management system certified production

Container Recycling

Pharmaceutical container return and recycling programs

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art pharmaceutical manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent pharmaceutical grade Baloxavir Marboxil quality and performance across all production batches.

Production Process

Advanced synthesis and purification in controlled cGMP environment

Multi-stage purification for pharmaceutical grade quality
Quality Testing

Comprehensive analytical testing protocol including purity, impurities, and stability

HPLC verification and spectroscopic analysis
Quality Systems

ISO 9001:2015 quality management with pharmaceutical manufacturing accreditation

Continuous improvement and process validation
Packaging Control

Pharmaceutical containers with controlled atmosphere packaging

Stability protection and contamination prevention

Market Applications & Performance Data

Comprehensive pharmaceutical development data demonstrating pharmaceutical grade Baloxavir Marboxil effectiveness across diverse therapeutic applications with quantified performance metrics and clinical study validations.

Pharmaceutical Manufacturing
Purity: >99.5% pharmaceutical grade Bioavailability: Consistent antiviral levels Stability: 36+ months under controlled conditions
Research Institutions
Clinical Studies: 150+ published research applications Reproducibility: >98% batch-to-batch consistency Innovation: Custom grade development
Generic Manufacturing
Regulatory Success: 100% FDA approval support Cost Efficiency: 25% reduction in manufacturing costs Quality Assurance: Zero batch failures

DRAVYOM Competitive Advantages

Superior Purity

Consistently exceeds pharmaceutical specifications with ultra-low impurities and exceptional therapeutic performance

Reliable Supply

Guaranteed availability with strategic inventory management and pharmaceutical-grade production scheduling

Pharmaceutical Expertise

Dedicated pharmaceutical development team provides formulation and regulatory support

Quality Assurance

Traceable certificates with comprehensive analytical data and regulatory compliance support

Global Standards

International compliance with USP, EP, and ICH specifications for worldwide acceptance

Partnership Approach

Collaborative relationships with pharmaceutical manufacturers and custom development services