Ofloxacin
Pharmaceutical Premium
Pharmaceutical API

Ofloxacin

High-purity pharmaceutical grade Ofloxacin 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: C18H20FN3O4
CAS Number: 82419-36-1
EINECS Number: 279-939-6
Purity (HPLC): ≥99.0% (USP/EP Grade)
Physical State: Yellow to light yellow crystalline powder
Molecular Weight: 361.37 g/mol
Melting Point: 269-272°C
pH (1% solution): 5.5-7.5
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals: ≤10 ppm
Solubility: Sparingly soluble in water
Storage Conditions: Store below 25°C, protect from light
Shelf Life: 3 years from manufacture date
Packaging Options: 25kg, 50kg fiber drums

Applications

Antibiotic Formulations
Ophthalmic Solutions
Otic Preparations
Oral Tablet Formulations
Injectable Solutions
Antimicrobial Therapy
Respiratory Infections
Urinary Tract Infections
Clinical Research
Pharmaceutical Development
Antimicrobial Studies
Regulatory Compliance

Industry-Specific Grades

DRAVYOM offers specialized Ofloxacin grades tailored for specific antibiotic applications, ensuring optimal antimicrobial efficacy and regulatory compliance across diverse pharmaceutical formulations.

USP Grade (United States Pharmacopoeia)
Purity: ≥99.0% Water Content: ≤0.5% Heavy Metals: ≤10 ppm Application: FDA approved formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% Related Substances: ≤1.0% Residual Solvents: EP limits Application: European market compliance
Ophthalmic Grade
Purity: ≥99.5% Sterility: Assured Endotoxins: <0.5 EU/mg Application: Eye drop formulations
Injectable Grade
Purity: ≥99.5% Particulate Matter: Controlled Pyrogens: USP limits Application: IV formulations

Quality Standards

DRAVYOM's Ofloxacin is manufactured under stringent cGMP protocols, meeting international antibiotic standards including USP, EP, and FDA guidelines for antimicrobial applications.

cGMP Manufacturing Standards
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Microbiological Testing
Antimicrobial Activity Verified
Batch-to-Batch Consistency
Comprehensive COA Documentation
Controlled Storage & Shipping

Advanced Chemical Properties & Performance

Pharmaceutical Grade Ofloxacin exhibits exceptional chemical properties essential for antimicrobial applications. Its potent fluoroquinolone structure and superior stability characteristics ensure reliable performance in demanding antibiotic formulations.

Molecular Properties
Molecular Weight: 361.37 g/mol
Molecular Formula: C18H20FN3O4
LogP (Octanol/Water): 0.35
pKa: 6.05, 8.22
Physical Properties
Melting Point: 269-274°C
Appearance: Pale yellow crystalline powder
Solubility (Water): 28 mg/mL at 25°C
Bulk Density: 0.45-0.55 g/cm³
Pharmaceutical Properties
Bioavailability: 85-95%
Protein Binding: 32%
Half-life: 4-7 hours
Mechanism: DNA gyrase and topoisomerase IV inhibition
Quality Specifications
Purity (HPLC): ≥99.0%
Water Content: ≤0.5%
Related Substances: ≤1.0%
Heavy Metals: ≤10 ppm
Stability Properties
Shelf Life: 3 years (unopened)
Storage Temperature: 15-25°C
Light Sensitivity: Store in light-resistant containers
Moisture Sensitivity: Store in dry conditions

Performance Characteristics

Detailed performance metrics demonstrate Ofloxacin superiority in antimicrobial applications with exceptional broad-spectrum activity, tissue penetration, and therapeutic efficacy across diverse bacterial infection treatment protocols.

Broad-Spectrum Activity

Effective against Gram-positive and Gram-negative bacteria

Enhanced antimicrobial coverage
DNA Gyrase Inhibition

Potent bacterial DNA replication inhibition

Rapid bactericidal action
Ophthalmic Excellence

Superior ocular penetration and efficacy

Optimal eye infection treatment
Urinary Tract Efficacy

High urinary concentrations achieved

Excellent UTI treatment
Clinical Performance

FDA-approved for multiple indications

Proven therapeutic effectiveness
Formulation Versatility

Compatible with oral and injectable forms

Flexible pharmaceutical applications

Safety Information

Pharmaceutical active ingredient requiring careful handling protocols. Handle in controlled environments with appropriate ventilation systems. Use proper personal protective equipment and follow established safety protocols for fluoroquinolone antibiotics.

Photosensitivity Risk
Controlled Handling Required
Specialized PPE Required

Storage & Handling

Store in tightly closed, light-resistant containers in a cool, dry place away from direct sunlight. Maintain controlled room temperature storage and ensure protection from moisture and humidity to preserve pharmaceutical quality and antimicrobial potency.

Controlled room temperature (15-25°C)
Protect from light (photosensitive)
Light-resistant containers mandatory
Store in dry conditions

Chemical Mechanisms & Reaction Pathways

Ofloxacin demonstrates potent antibacterial activity through DNA gyrase and topoisomerase IV inhibition, providing broad-spectrum coverage against gram-positive and gram-negative bacteria with excellent tissue penetration.

DNA Gyrase Inhibition

Blocking bacterial DNA replication and transcription

Bactericidal activity against dividing bacteria
Topoisomerase IV

Preventing bacterial chromosome decatenation

Additional mechanism for bacterial killing
Broad Spectrum

Activity against gram-positive and gram-negative bacteria

Versatile antibacterial coverage
Pharmacokinetic Profile

Excellent oral bioavailability and tissue distribution

Therapeutic drug levels in target tissues

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical acceptance with complete documentation packages supporting international drug development and manufacturing requirements.

USP Specifications

United States Pharmacopeia pharmaceutical grade compliance

EP Standards

European Pharmacopoeia specifications and testing protocols

ICH Guidelines

International harmonized pharmaceutical development standards

Global Regulatory

Multi-regional pharmaceutical registration support

DMF Support

Drug Master File preparation and regulatory submission

GMP Compliance

Good Manufacturing Practice certified production

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, analytical method development, and regulatory assistance to optimize Ofloxacin performance in pharmaceutical applications.

Formulation Development
  • Tablet and capsule formulations
  • Ophthalmic solutions
  • Injectable preparations
  • Stability enhancement strategies
Analytical Services
  • Method validation and transfer
  • Impurity profiling and identification
  • Stability testing programs
  • Microbiological testing
Regulatory Support
  • Regulatory strategy development
  • Documentation preparation
  • Regulatory submission support
  • Global compliance guidance
Supply Solutions
  • Reliable supply chain management
  • Flexible packaging options
  • Emergency supply arrangements
  • Global distribution network

Environmental Impact & Sustainability

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

Green Chemistry

Environmentally conscious synthesis with minimal waste

Water Management

Advanced wastewater treatment and recycling systems

Energy Efficiency

Optimized manufacturing processes with reduced energy consumption

Waste Reduction

Comprehensive waste minimization and disposal protocols

ISO 14001

Environmental management system certified production

Carbon Footprint

Reduced environmental impact through sustainable practices

Manufacturing Excellence & Quality Control

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

GMP Production

Good Manufacturing Practice certified facility with controlled environments

Pharmaceutical-grade production standards
Quality Testing

Comprehensive analytical testing including potency and purity

HPLC, UV-VIS, and microbiological methods
Quality Systems

ISO 9001:2015 quality management with pharmaceutical compliance

Continuous improvement and validation protocols
Packaging Control

Controlled atmosphere packaging with light protection

Stability maintenance and protection systems

Market Applications & Performance Data

Comprehensive pharmaceutical data demonstrating Ofloxacin effectiveness across diverse therapeutic applications with quantified performance metrics and clinical validation.

Pharmaceutical Manufacturing
Bioavailability: ~95% oral absorption Stability: 3+ years shelf life Purity: >99.5% pharmaceutical grade
Drug Development
Formulation Support: Multiple dosage forms Regulatory Success: Global approvals achieved Innovation: Novel delivery systems
Clinical Applications
Efficacy: Proven antibacterial activity Safety: Well-established safety profile Versatility: Multiple therapeutic indications

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Consistently exceeds USP/EP specifications with pharmaceutical-grade quality and performance

Reliable Supply

Guaranteed availability with strategic inventory management and pharmaceutical-grade production

Development Expertise

Dedicated pharmaceutical team provides formulation development and regulatory support

Quality Assurance

Comprehensive documentation with pharmaceutical-grade certificates and regulatory compliance

Global Standards

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

Partnership Approach

Collaborative relationships with pharmaceutical companies and custom development services