Azacitidine
High-purity pharmaceutical grade Azacitidine API manufactured to meet stringent USP/EP specifications for cancer treatment formulations. Our pharmaceutical grade API delivers exceptional purity and consistency for critical oncology drug manufacturing applications.
- USP/EP Grade Quality Standards
- High Purity ≥99.0% (HPLC)
- Comprehensive Analytical Documentation
- Regulatory Compliance Support
- cGMP Manufacturing Standards
- Pharmaceutical Grade Packaging
Technical Specifications
Applications
Industry-Specific Grades
DRAVYOM offers specialized Azacitidine grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse oncology drug manufacturing applications.
USP Grade (Pharmaceutical)
EP Grade (European Pharmacopoeia)
Research Grade
GMP Grade
Quality Standards
DRAVYOM's pharmaceutical grade Azacitidine 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.
Advanced Chemical Properties & Performance
Pharmaceutical grade Azacitidine exhibits exceptional chemical properties essential for oncology therapy applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and research applications.
Analytical Properties
Physical Properties
Pharmaceutical Performance
Purity Specifications
Stability Properties
Performance Characteristics
Detailed performance metrics demonstrate pharmaceutical grade Azacitidine superiority in oncology applications with exceptional DNA methyltransferase inhibition efficacy, precision, and reproducibility across diverse myelodysplastic syndrome treatment protocols and research procedures.
Pharmaceutical Performance
Assay: ≥98.0% active pharmaceutical ingredient
Exceptional purity for oncology formulationsEpigenetic Activity
Mechanism: DNA methyltransferase inhibition
Superior hypomethylating activityDissolution Rate
Bioavailability: 89% subcutaneous
Optimized systemic exposureCold Storage Stability
Working range: -20°C storage
Maintains potency under frozen conditionsBatch Consistency
Variation: ±0.2% between manufacturing batches
Exceptional lot-to-lot reproducibilityExtended Stability
3 years shelf life under recommended conditions
Long-term pharmaceutical grade integritySafety Information
Cytotoxic oncological pharmaceutical requiring specialized handling procedures. Use appropriate personal protective equipment and follow institutional cytotoxic drug handling protocols. Avoid skin contact and inhalation. Handle in well-ventilated areas with specialized safety cabinets for cytotoxic compounds.
Storage & Handling
Store in original containers in a freezer (-20°C) away from light and incompatible materials. Keep containers tightly closed and protect from moisture and temperature fluctuations. Use specialized cytotoxic storage protocols with dedicated freezer space and ensure proper material identification and segregation.
Chemical Mechanisms & Reaction Pathways
Azacitidine exhibits DNA methyltransferase inhibition properties through cytidine analog incorporation, enabling precise antineoplastic applications with predictable methylation pathway disruption and quantitative cytotoxic enhancement mechanisms.
DNA Incorporation
Direct incorporation into DNA and RNA strands during synthesis
Quantitative methyltransferase enzyme inhibitionHypomethylation
Reduction of DNA methylation in cancer cells
Essential for epigenetic therapy mechanismsCell Cycle Arrest
S-phase arrest leading to apoptosis in malignant cells
Enables targeted oncological efficacyMetabolic Activation
Phosphorylation to active triphosphate metabolite
Predictable pharmaceutical activation pathwayRegulatory Compliance & Documentation
Comprehensive regulatory compliance ensures global pharmaceutical access with complete documentation packages supporting international standards and pharmaceutical manufacturing validations.
USP Specifications
United States Pharmacopeia pharmaceutical standards compliance
EP Standards
European Pharmacopoeia specifications for pharmaceutical analysis
ICH Guidelines
International Conference on Harmonization pharmaceutical compliance
FDA Registration
United States Food and Drug Administration compliance
Method Validation
Supported analytical method validation documentation
SDS Documentation
Multi-language Safety Data Sheets (16 sections, GHS compliant)
Technical Support & Value-Added Services
DRAVYOM's pharmaceutical development team provides comprehensive formulation support, stability testing assistance, and regulatory services to optimize pharmaceutical grade Azacitidine performance in your specific therapeutic applications.
Formulation Development
- Pharmaceutical formulation optimization support
- Stability testing guidance
- Bioavailability and bioequivalence validation
- Custom pharmaceutical procedures
Analytical Services
- Certificate of Analysis verification
- Custom purity analysis
- Impurity profiling and identification
- Method validation support
Technical Support
- Pharmaceutical troubleshooting consultation
- Storage and handling guidance
- Safety training and protocols
- Manufacturing best practices
Supply Solutions
- Consistent batch scheduling
- Emergency supply arrangements
- Custom packaging options
- Global distribution network
Environmental Impact & Sustainability
Our pharmaceutical grade Azacitidine production emphasizes environmental responsibility through sustainable manufacturing practices, waste minimization, and comprehensive environmental impact management for pharmaceutical operations.
Waste Minimization
Optimized production with minimal waste generation
Water Treatment
Advanced wastewater treatment and recycling systems
Clean Production
Energy-efficient synthesis with emission controls
Safe Disposal
Comprehensive guidance for pharmaceutical waste management
ISO 14001
Environmental management system certified production
Container Recycling
Pharmaceutical container return and recycling programs
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 grade Azacitidine quality and performance across all production batches.
Production Process
Advanced synthesis and purification in controlled cGMP environment
Multi-stage purification for pharmaceutical grade qualityQuality Testing
Comprehensive analytical testing protocol including purity, impurities, and stability
HPLC verification and spectroscopic analysisQuality Systems
ISO 9001:2015 quality management with pharmaceutical manufacturing accreditation
Continuous improvement and process validationPackaging Control
Pharmaceutical containers with controlled atmosphere packaging
Stability protection and contamination preventionMarket Applications & Performance Data
Comprehensive pharmaceutical development data demonstrating pharmaceutical grade Azacitidine effectiveness across diverse therapeutic applications with quantified performance metrics and clinical study validations.
Pharmaceutical Manufacturing
Research Institutions
Generic Manufacturing
DRAVYOM Competitive Advantages
Superior Purity
Consistently exceeds pharmaceutical specifications with ultra-low impurities and exceptional therapeutic performance
Reliable Supply
Guaranteed availability with strategic inventory management and pharmaceutical-grade production scheduling
Pharmaceutical Expertise
Dedicated pharmaceutical development team provides formulation and regulatory support
Quality Assurance
Traceable certificates with comprehensive analytical data and regulatory compliance support
Global Standards
International compliance with USP, EP, and ICH specifications for worldwide acceptance
Partnership Approach
Collaborative relationships with pharmaceutical manufacturers and custom development services