Vortioxetine HBR
High-purity pharmaceutical grade Vortioxetine HBR API manufactured to meet stringent USP/EP specifications for antidepressant medication production. Our pharmaceutical-grade Vortioxetine HBR delivers exceptional quality and consistency for critical pharmaceutical applications.
- USP/EP Compliant Grade
- High Purity (>99.5%)
- Multimodal Antidepressant
- GMP Certified Manufacturing
- Reliable Supply Chain
- Complete Documentation
Technical Specifications
Applications
Industry-Specific Grades
DRAVYOM offers specialized Vortioxetine HBR grades tailored for specific psychiatric pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse antidepressant therapeutic applications.
USP Grade (United States Pharmacopeia)
EP Grade (European Pharmacopoeia)
Psychiatric Grade
Research Grade
Quality Standards
DRAVYOM's Vortioxetine HBR is manufactured under stringent quality control protocols, meeting international pharmaceutical standards including USP, EP specifications. Our antidepressant-grade production ensures consistent performance and regulatory compliance.
Advanced Chemical Properties & Performance
Vortioxetine HBR exhibits exceptional multimodal antidepressant properties essential for psychiatric applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding antidepressant formulations.
Molecular Properties
Physical Properties
Pharmaceutical Performance
Purity Specifications
Stability Properties
Performance Characteristics
Detailed performance metrics demonstrate Vortioxetine HBR superiority in psychiatric applications with exceptional multimodal antidepressant activity, bioavailability, and reproducibility across diverse formulations.
Multimodal Activity
SERT inhibition + receptor modulation
Comprehensive antidepressant actionBioavailability
Oral: 75% absolute bioavailability
Excellent drug absorptionStability
Solid state: >5 years stability
Long-term pharmaceutical integrityThermal Stability
Working range: 15-40°C processing
Stable during formulationBatch Reproducibility
Variation: ±0.5% between batches
Consistent lot-to-lot performanceShelf Stability
5 years under proper storage conditions
Extended pharmaceutical grade integritySafety Information
Pharmaceutical grade psychiatric API requiring careful handling. Handle with appropriate protective equipment in controlled environments. Avoid skin contact and inhalation. Follow cGMP guidelines for psychiatric APIs and ensure proper waste disposal procedures.
Storage & Handling
Store in original sealed containers in a cool, dry, well-ventilated area away from light and moisture. Keep containers tightly closed and protect from direct sunlight. Use appropriate containment measures for pharmaceutical API handling.
Chemical Mechanisms & Reaction Pathways
Vortioxetine HBR functions through multimodal serotonergic activity combining selective serotonin reuptake inhibition with direct receptor modulation, enabling enhanced antidepressant efficacy with well-characterized neuropsychiatric pathways.
SERT Inhibition
Potent selective inhibition of serotonin transporter (SERT)
Increases synaptic serotonin concentrationsReceptor Modulation
Direct modulation of 5-HT3, 5-HT7, 5-HT1A, and 5-HT1B receptors
Enhances cognitive and mood benefitsMetabolic Pathways
Hepatic metabolism via CYP2D6 with multiple active metabolites
Linear pharmacokinetics with predictable dosingTherapeutic Action
Antidepressant activity with cognitive enhancement and improved tolerability
Reduced sexual side effects compared to SSRIsRegulatory Compliance & Documentation
Comprehensive regulatory compliance ensures global pharmaceutical manufacturing access with complete documentation packages supporting international standards and pharmaceutical development requirements.
USP/EP Standards
United States Pharmacopeia and European Pharmacopoeia compliance
ICH Guidelines
International Conference on Harmonisation pharmaceutical standards
cGMP Manufacturing
Current Good Manufacturing Practice certified production
Global Registration
DMF filings and regulatory support for worldwide markets
Stability Studies
Long-term and accelerated stability data packages
Impurity Profiling
Comprehensive impurity identification and qualification
Technical Support & Value-Added Services
DRAVYOM's pharmaceutical development team provides comprehensive formulation support, analytical method development, and regulatory assistance to optimize pharmaceutical manufacturing processes and ensure successful product development.
Formulation Development
- API compatibility studies
- Excipient interaction analysis
- Stability-indicating method development
- Formulation optimization support
Analytical Services
- Method validation and transfer
- Impurity profiling and identification
- Forced degradation studies
- Bioanalytical method development
Technical Support
- Pharmaceutical development consultation
- Manufacturing process optimization
- Quality system implementation
- Regulatory filing support
Supply Solutions
- Clinical trial material supply
- Commercial scale manufacturing
- Just-in-time delivery programs
- Global supply chain management
Environmental Impact & Sustainability
Our pharmaceutical API production emphasizes environmental responsibility through sustainable manufacturing practices, waste minimization, and comprehensive environmental impact management for pharmaceutical operations.
Green Chemistry
Optimized synthetic routes with minimal environmental impact
Solvent Recovery
Advanced solvent recovery and recycling systems
Energy Efficiency
Renewable energy integration in manufacturing processes
Waste Management
Comprehensive pharmaceutical waste treatment protocols
ISO 14001
Environmental management system certified operations
Packaging Innovation
Sustainable packaging materials and design optimization
Manufacturing Excellence & Quality Control
DRAVYOM's state-of-the-art pharmaceutical manufacturing facility employs advanced process control technology and comprehensive quality systems to ensure consistent API quality and performance across all production batches.
cGMP Manufacturing
Current Good Manufacturing Practice compliant production in controlled environments
FDA and EMA inspected pharmaceutical facilitiesQuality Control
Multi-point quality control testing including assay, related substances, and residual solvents
HPLC, GC-MS, and NMR analytical verificationQuality Systems
ISO 9001:2015 quality management with pharmaceutical quality system standards
Continuous improvement and change control proceduresPackaging Systems
Primary packaging in controlled atmosphere with tamper-evident sealing
Light protection and moisture barrier packagingMarket Applications & Performance Data
Comprehensive pharmaceutical development data demonstrating API effectiveness across diverse therapeutic applications with quantified performance metrics and regulatory validation studies.
Pharmaceutical Manufacturing
Research & Development
Clinical Applications
DRAVYOM Competitive Advantages
Pharmaceutical Excellence
Consistently exceeds USP/EP specifications with exceptional purity and pharmaceutical performance standards
Reliable Supply Chain
Guaranteed pharmaceutical-grade availability with strategic inventory management and production scheduling
Development Expertise
Dedicated pharmaceutical development team provides formulation and analytical method support
Regulatory Excellence
Comprehensive documentation packages with global regulatory filing support and validation
Global Standards
International compliance with USP, EP, JP, and ICH guidelines for worldwide pharmaceutical acceptance
Partnership Excellence
Collaborative pharmaceutical development relationships with custom API synthesis and scale-up services