Fluoxetine
Pharmaceutical Premium
Pharmaceutical API

Fluoxetine

High-purity pharmaceutical grade Fluoxetine 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: C17H18F3NO
CAS Number: 54910-89-3
Molecular Weight: 309.33 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 (15-25°C)
Packaging Options: 1kg, 5kg pharmaceutical containers

Applications

Antidepressant Drug Manufacturing
SSRI Treatment Formulations
Mental Health Products
API Synthesis & Development
Neurological 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 Fluoxetine grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse antidepressant and SSRI 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: Antidepressant formulations

Quality Standards

DRAVYOM's pharmaceutical grade Fluoxetine 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 Fluoxetine exhibits precise chemical properties essential for antidepressant formulations. Its ultra-pure composition and exact molecular structure ensure reliable therapeutic performance in demanding pharmaceutical applications.

Pharmaceutical Properties
Molecular Weight: 309.33 g/mol
Melting Point: 158-162°C
Solubility (Water): 14 mg/mL at 25°C
LogP (Octanol/Water): 4.05
Physical Properties
Appearance: White to off-white powder
Crystalline Form: Crystalline solid
Bulk Density: 0.45-0.55 g/mL
Hygroscopicity: Non-hygroscopic
Pharmaceutical Performance
Bioavailability: 95% oral bioavailability
Half-life: 4-6 days
Protein Binding: 94.5%
Metabolism: Hepatic (CYP2D6)
Purity Specifications
Assay: ≥99.0% (HPLC)
Related Substances: ≤0.1% total
Residual Solvents: ICH Q3C compliant
Heavy Metals: ≤10 ppm
Stability Properties
Shelf Life: 3 years (unopened)
Storage Temperature: 15-30°C
Light Sensitivity: Protect from light
Moisture Sensitivity: Store in dry conditions

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Fluoxetine superiority in therapeutic applications with exceptional bioavailability, stability, and reproducibility across diverse pharmaceutical formulations.

Formulation Performance

Compatibility: Excellent with standard excipients

Consistent tablet hardness and dissolution
Therapeutic Efficacy

Bioequivalence: 95-105% reference standard

Proven therapeutic equivalence
Dissolution Profile

Release: >85% in 30 minutes (USP)

Optimal pharmaceutical performance
Thermal Stability

Stability: <0.1% degradation/year at 25°C

Excellent long-term stability
Batch Consistency

Variation: ±0.5% between production batches

Exceptional pharmaceutical uniformity
Shelf Stability

3 years under controlled storage conditions

Extended pharmaceutical grade integrity

Safety Information

Pharmaceutical grade compound requiring proper handling procedures. Use appropriate personal protective equipment including gloves, safety goggles, and protective clothing. Ensure adequate ventilation and follow established pharmaceutical handling protocols.

Handle with Care
Eye Protection Required
Avoid Inhalation

Storage & Handling

Store in original pharmaceutical containers in a cool, dry, well-ventilated area away from incompatible materials. Keep containers tightly closed and protect from light and moisture. Follow cGMP storage requirements for pharmaceutical materials.

Controlled temperature (15-30°C)
Protect from moisture
Original pharmaceutical packaging
Protect from direct light

Chemical Mechanisms & Reaction Pathways

Fluoxetine exhibits selective serotonin reuptake inhibition through competitive binding at the serotonin transporter, providing effective treatment for depression, anxiety disorders, and obsessive-compulsive disorder.

SSRI Mechanism

Selective serotonin reuptake transporter inhibition

Increases synaptic serotonin levels
Neuroplasticity

Promotes neurogenesis and synaptic plasticity

Long-term antidepressant effects
Long Half-Life

Extended elimination half-life and active metabolites

Sustained therapeutic effect
Selective Activity

High selectivity for serotonin vs other neurotransmitters

Reduced side effect profile

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures psychiatric pharmaceutical manufacturing access with complete documentation packages supporting international standards and antidepressant therapy development.

USP Standards

United States Pharmacopeia psychiatric drug specifications

EP Monograph

European Pharmacopoeia specifications for SSRI antidepressants

Psychiatric GMP

Specialized GMP for psychiatric drug manufacturing

ICH Guidelines

International psychiatric drug development regulatory compliance

Psychiatric DMF

Drug Master File for psychiatric applications

Safety Documentation

Comprehensive psychiatric safety and pharmacovigilance documentation

Technical Support & Value-Added Services

DRAVYOM's psychiatric pharmaceutical team provides comprehensive formulation support, stability testing, and regulatory services for Fluoxetine antidepressant therapy applications.

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

Environmental Impact & Sustainability

Our Fluoxetine production emphasizes environmental responsibility through sustainable pharmaceutical 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 synthesis technology and continuous monitoring systems to ensure consistent Fluoxetine quality and psychiatric 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 psychiatric 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 psychiatric data demonstrating Fluoxetine effectiveness in depression and anxiety disorders with quantified performance metrics and clinical validation data.

Psychiatric Formulations
Bioavailability: 95% oral bioavailability Stability: 5-year shelf life validated Compatibility: Excellent with capsule excipients
Therapeutic Applications
Depression: Proven major depressive disorder treatment Anxiety: Effective anxiety disorder therapy Safety: Well-tolerated SSRI profile
Manufacturing Performance
Yield: 92% pharmaceutical grade recovery Purity: >99.0% pharmaceutical specification Consistency: 99.5% batch-to-batch reproducibility

DRAVYOM Competitive Advantages

Psychiatric Excellence

Superior pharmaceutical grade with proven SSRI selectivity and regulatory compliance

Reliable Supply

Guaranteed psychiatric supply with strategic inventory management and specialized production

Mental Health Expertise

Dedicated psychiatric development team with specialized antidepressant formulation support

Regulatory Compliance

Complete psychiatric documentation with DMF support and international compliance

Global Standards

International pharmaceutical compliance with USP, EP, and ICH guidelines

Partnership Approach

Collaborative psychiatric relationships with specialized development services