Fidaxomicin
Pharmaceutical Premium
Pharmaceutical API

Fidaxomicin

High-purity pharmaceutical grade Fidaxomicin manufactured to meet stringent USP/EP specifications for pharmaceutical formulations and research applications. Our pharmaceutical grade material delivers exceptional purity and consistency for critical pharmaceutical manufacturing.

  • USP/EP Grade Specifications
  • High Purity (≥99.0%)
  • Comprehensive Analytical Testing
  • Regulatory Compliance Documentation
  • Pharmaceutical Manufacturing Grade
  • Quality Assurance Certified
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Technical Specifications

Chemical Formula: C52H74Cl2O18
CAS Number: 873857-62-6
Molecular Weight: 1058.04 g/mol
Purity (HPLC): ≥99.0% (pharmaceutical grade)
Physical State: White to off-white powder
Water Content (Karl Fischer): ≤5.0%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% total impurities
Storage Conditions: Store in cool, dry place (15-25°C)
Packaging Options: 100g, 500g pharmaceutical containers

Applications

Antibiotic Drug Manufacturing
C. difficile Treatment Formulations
Macrolide Antibiotic Products
API Synthesis & Development
Antimicrobial 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 Fidaxomicin grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse antibiotic and C. difficile treatment drug manufacturing applications.

USP Grade (Pharmaceutical)
Purity: ≥99.0% (HPLC) Water Content: ≤5.0% 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: ≤6.0% Particle Size: Controlled Application: R&D, method development
GMP Grade
Purity: ≥99.5% (pharmaceutical) Endotoxins: ≤2.5 EU/mg Microbial Limits: Compliant Application: Antibiotic formulations

Quality Standards

DRAVYOM's pharmaceutical grade Fidaxomicin 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
Ultra-Low Impurities
Batch-to-Batch Consistency
Traceable Certificate of Analysis
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

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

Analytical Properties
Solubility (Water): Practically insoluble
LogP (octanol/water): 0.2
pKa: 6.8
Molecular Weight: 1058.04 g/mol
Physical Properties
Appearance: White to off-white powder
Melting Point: Decomposes >200°C
Bulk Density: 0.3-0.5 g/mL
Hygroscopicity: Hygroscopic
Pharmaceutical Performance
Bioavailability: Minimal systemic absorption
Protein Binding: 80%
Half-life: 11.7 hours
Mechanism: RNA polymerase inhibitor
Purity Specifications
Assay (HPLC): ≥99.0%
Related Substances: ≤1.0% total
Water Content: ≤6.0% (Karl Fischer)
Residue on Ignition: ≤0.5%
Stability Properties
Shelf Life: 2 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Store below 25°C
Moisture Sensitivity: Protect from moisture

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Fidaxomicin superiority in antibiotic applications with exceptional C. difficile activity, minimal systemic absorption, and reproducibility across diverse therapeutic protocols.

C. difficile Activity

Potent activity against C. difficile

Selective gut activity
Microbiome Preservation

Minimal impact on normal flora

Reduced recurrence risk
Stability Profile

Chemical stability: Good under storage conditions

Maintains potency for 2 years
Thermal Stability

Decomposes >200°C

Stable during processing
Batch Reproducibility

Variation: ±0.2% between batches

Consistent therapeutic efficacy
Oral Delivery

Designed for oral administration

Targeted gut action

Safety Information

Pharmaceutical antibiotic requiring professional handling protocols. Well-established safety profile for C. difficile therapy applications. Handle with appropriate pharmaceutical-grade safety precautions and ensure proper GMP environmental controls. Clinical monitoring for allergic reactions and drug interactions during therapeutic use.

Pharmaceutical Grade
Professional Use
Monitor for allergic reactions

Storage & Handling

Store in original containers in a cool, dry, well-ventilated area away from moisture and light. Keep containers tightly closed and maintain pharmaceutical-grade environmental controls. Use appropriate GMP handling techniques for API processing.

Cool storage (15-25°C)
Protect from moisture
Protect from light
GMP handling required

Chemical Mechanisms & Reaction Pathways

Fidaxomicin exhibits selective bactericidal activity against Clostridium difficile through RNA polymerase inhibition, providing targeted treatment for C. difficile infections with minimal disruption to beneficial gut microbiota.

RNA Polymerase Inhibition

Selective bacterial RNA polymerase enzyme inhibition

Blocks bacterial protein synthesis
C. difficile Selectivity

Targeted activity against Clostridium difficile

Preserves beneficial gut bacteria
Bactericidal Action

Rapid killing of C. difficile vegetative cells

Effective infection control
Low Systemic Absorption

Minimal systemic absorption and gut-targeted action

Reduced systemic side effects

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures antibiotic pharmaceutical manufacturing access with complete documentation packages supporting international standards and C. difficile infection treatment development.

USP Standards

United States Pharmacopeia antibiotic drug specifications

EP Monograph

European Pharmacopoeia specifications for macrocyclic antibiotics

Antibiotic GMP

Specialized GMP for antibiotic drug manufacturing

ICH Guidelines

International antibiotic drug development regulatory compliance

Antibiotic DMF

Drug Master File for antibiotic applications

Safety Documentation

Comprehensive antibiotic safety and pharmacovigilance documentation

Technical Support & Value-Added Services

DRAVYOM's antibiotic pharmaceutical team provides comprehensive formulation support, stability testing, and regulatory services for Fidaxomicin C. difficile treatment applications.

Antibiotic Formulation
  • C. difficile antibiotic formulation optimization
  • Oral tablet development
  • Bioavailability enhancement
  • Custom antibiotic development
Analytical Services
  • API purity and potency analysis
  • Antibiotic impurity profiling
  • Stability testing protocols
  • Method validation support
Regulatory Support
  • Antibiotic regulatory filing
  • DMF preparation and maintenance
  • International compliance guidance
  • Antibiotic pharmacovigilance
Supply Solutions
  • Antibiotic pharmaceutical supply chain
  • Custom packaging solutions
  • Global distribution network
  • Emergency antibiotic supply

Environmental Impact & Sustainability

Our Fidaxomicin production emphasizes environmental responsibility through sustainable antibiotic manufacturing practices, waste minimization, and comprehensive environmental impact management.

Green Chemistry

Environmentally friendly synthesis and processing methods

Water Conservation

Advanced water treatment and recycling systems

Clean Production

Energy-efficient pharmaceutical manufacturing processes

Waste Reduction

Comprehensive pharmaceutical waste management protocols

ISO 14001

Environmental management system certified production

Sustainable Sourcing

Responsible procurement of pharmaceutical raw materials

Manufacturing Excellence & Quality Control

DRAVYOM's pharmaceutical manufacturing facility employs advanced fermentation and synthesis technology with continuous monitoring systems to ensure consistent Fidaxomicin quality and antibiotic therapeutic performance.

Pharmaceutical GMP

Advanced manufacturing in controlled clean-room environment

Multi-stage purification for pharmaceutical grade quality
Quality Testing

Comprehensive testing including assay, impurities, and stability

HPLC verification and antibiotic analysis
Quality Systems

ISO 9001:2015 quality management with pharmaceutical compliance

Continuous improvement and pharmaceutical validation
Pharmaceutical Packaging

Pharmaceutical-grade containers with moisture protection

Stability protection and contamination prevention

Market Applications & Performance Data

Comprehensive antibiotic data demonstrating Fidaxomicin effectiveness in C. difficile infection treatment with quantified performance metrics and clinical validation data.

Antibiotic Formulations
Bioavailability: Minimal systemic absorption Stability: 3-year shelf life validated Compatibility: Excellent with tablet excipients
Therapeutic Applications
C. difficile: Proven Clostridium difficile infection treatment Gut Protection: Preserves beneficial microbiota Safety: Selective antibiotic activity profile
Manufacturing Performance
Yield: 92% pharmaceutical grade recovery Purity: >98.5% pharmaceutical specification Consistency: 99.5% batch-to-batch reproducibility

DRAVYOM Competitive Advantages

Antibiotic Excellence

Superior pharmaceutical grade with proven C. difficile selectivity and regulatory compliance

Reliable Supply

Guaranteed antibiotic supply with strategic inventory management and specialized production

Infection Medicine Expertise

Dedicated infectious disease development team with specialized antibiotic formulation support

Regulatory Compliance

Complete antibiotic documentation with DMF support and international compliance

Global Standards

International pharmaceutical compliance with USP, EP, and ICH guidelines

Partnership Approach

Collaborative antibiotic relationships with specialized development services