Quetiapine Fumarate
High-purity pharmaceutical grade Quetiapine Fumarate API manufactured to meet stringent USP/EP specifications for antipsychotic medication production. Our pharmaceutical-grade Quetiapine Fumarate delivers exceptional quality and consistency for critical pharmaceutical applications.
- USP/EP Compliant Grade
- High Purity (>99.5%)
- Atypical Antipsychotic
- GMP Certified Manufacturing
- Reliable Supply Chain
- Complete Documentation
Technical Specifications
Applications
Industry-Specific Grades
DRAVYOM offers specialized Quetiapine Fumarate grades tailored for specific psychiatric applications, ensuring optimal atypical antipsychotic activity and regulatory compliance across diverse pharmaceutical formulations.
USP Grade (United States Pharmacopoeia)
EP Grade (European Pharmacopoeia)
Research Grade
Extended-Release Grade
Quality Standards
DRAVYOM's Quetiapine Fumarate is manufactured under stringent cGMP protocols, meeting international pharmaceutical standards including USP, EP, and FDA guidelines for psychiatric medication applications.
Advanced Chemical Properties & Performance
Pharmaceutical Grade Quetiapine Fumarate exhibits exceptional chemical properties essential for antipsychotic applications. Its potent dibenzothiazepine structure and superior stability characteristics ensure reliable performance in demanding psychiatric disorder treatment formulations.
Molecular Properties
Physical Properties
Pharmaceutical Properties
Quality Specifications
Stability Properties
Performance Characteristics
Detailed performance metrics demonstrate Quetiapine Fumarate superiority in antipsychotic applications with exceptional dopamine and serotonin receptor modulation, mood stabilization, and therapeutic efficacy across diverse psychiatric disorder treatment protocols.
Antipsychotic Activity
Superior efficacy in schizophrenia and bipolar disorder
Positive and negative symptom controlReceptor Modulation
Multiple neurotransmitter receptor antagonism
D2, 5-HT2A, H1, α1-adrenergicMood Stabilization
Effective mood episode prevention
Manic and depressive episode controlDosing Flexibility
6-7 hour elimination half-life
Twice-daily dosing optionsClinical Efficacy
FDA-approved for multiple psychiatric conditions
Proven psychiatric benefitsFormulation Flexibility
Available in immediate and extended-release forms
Patient-specific dosing optionsSafety Information
Potent antipsychotic pharmaceutical active ingredient requiring specialized handling protocols. Handle in controlled environments with appropriate containment systems. Use proper personal protective equipment and follow established safety protocols for psychoactive compounds.
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 antipsychotic potency.
Chemical Mechanisms & Reaction Pathways
Quetiapine Fumarate exhibits specific dopamine and serotonin receptor antagonist mechanisms essential for antipsychotic therapeutic effects. Its molecular structure enables multi-receptor binding with predictable neuropsychiatric therapeutic responses.
Receptor Binding
Multi-receptor antagonist with D2, 5-HT2A, and H1 receptor affinity
Antipsychotic and sedative effectsMetabolic Pathways
Hepatic metabolism via CYP3A4 to active metabolite N-desalkylquetiapine
Dual parent-metabolite activityCNS Selectivity
Preferential central nervous system receptor distribution
Targeted neuropsychiatric actionPharmacological Effects
Antipsychotic, mood stabilizing, and sedative properties
Comprehensive psychiatric treatmentRegulatory Compliance & Documentation
Comprehensive regulatory compliance ensures global pharmaceutical access with complete documentation packages supporting international drug development and manufacturing standards.
USP Specifications
United States Pharmacopeia pharmaceutical standards compliance
EP Standards
European Pharmacopoeia specifications for pharmaceutical quality
ICH Guidelines
International Conference on Harmonization standards compliance
GMP Certification
Good Manufacturing Practices certified production facility
DMF Support
Drug Master File documentation for regulatory submissions
CEP Available
Certificate of Suitability to European Pharmacopoeia monographs
Technical Support & Value-Added Services
DRAVYOM's pharmaceutical development team provides comprehensive formulation support, regulatory assistance, and technical services to optimize pharmaceutical performance in your specific drug development applications.
Formulation Development
- Dosage form optimization support
- Stability testing guidance
- Bioavailability enhancement
- Custom formulation development
Analytical Services
- Method development and validation
- Impurity profiling and identification
- Stability indicating methods
- Dissolution testing support
Regulatory Support
- Regulatory submission assistance
- DMF preparation and maintenance
- Pharmacovigilance support
- Global registration strategy
Supply Solutions
- Pharmaceutical supply chain management
- Cold chain logistics
- Custom packaging solutions
- Global distribution network
Environmental Impact & Sustainability
Our pharmaceutical production emphasizes environmental responsibility through sustainable manufacturing practices, green chemistry principles, and comprehensive environmental impact management for pharmaceutical operations.
Green Chemistry
Sustainable synthetic routes with minimal environmental impact
Water Management
Advanced wastewater treatment and recycling systems
Clean Production
Energy-efficient synthesis with emission controls
Safe Disposal
Comprehensive pharmaceutical waste management protocols
ISO 14001
Environmental management system certified production
Sustainable Packaging
Recyclable pharmaceutical packaging solutions
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 quality and performance across all production batches.
Production Process
Advanced synthesis and purification in GMP-controlled clean-room environment
Multi-stage purification for pharmaceutical grade qualityQuality Testing
Comprehensive testing protocol including purity, potency, and impurity profiling
HPLC, GC-MS, and spectroscopic analysisQuality Systems
ISO 9001:2015 and GMP quality management systems
Continuous improvement and validation protocolsPackaging Control
Pharmaceutical-grade packaging with controlled atmosphere
Contamination prevention and stability protectionMarket Applications & Performance Data
Comprehensive pharmaceutical development data demonstrating effectiveness across diverse therapeutic applications with quantified performance metrics and clinical validation support.
Pharmaceutical Development
Research Applications
Commercial Manufacturing
DRAVYOM Competitive Advantages
Pharmaceutical Excellence
Consistently exceeds pharmacopeial specifications with superior purity and pharmaceutical performance
Reliable Supply
Guaranteed pharmaceutical availability with strategic inventory and GMP production scheduling
Development Expertise
Dedicated pharmaceutical development team provides formulation and regulatory support
Regulatory Assurance
Complete regulatory packages with DMF support and global registration assistance
Global Standards
International compliance with USP, EP, and ICH standards for worldwide market access
Partnership Approach
Collaborative relationships with pharmaceutical companies and custom development services