Decitabine API
Pharmaceutical Oncology
Oncology API

Decitabine

High-purity pharmaceutical grade Decitabine 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
Request Quote Technical Support

Technical Specifications

Chemical Formula: C8H12N4O4
CAS Number: 2353-33-5
Molecular Weight: 228.20 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 (2-8°C)
Packaging Options: 10mg, 50mg pharmaceutical vials

Applications

Cancer Drug Manufacturing
DNA Methyltransferase Inhibitor
Injectable Pharmaceutical Products
API Synthesis & Development
Myelodysplastic Syndrome Treatment
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 Decitabine grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse cancer 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: Oncology formulations

Quality Standards

DRAVYOM's pharmaceutical grade Decitabine 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
Comprehensive Impurity Control
Batch-to-Batch Consistency
Complete Documentation Package
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Pharmaceutical grade Decitabine 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
Solubility (Water): Soluble
LogP (octanol/water): -1.4
pKa: 3.5
Molecular Weight: 228.21 g/mol
Physical Properties
Appearance: White to off-white crystalline powder
Melting Point: 155-158°C
Bulk Density: 0.4-0.6 g/mL
Hygroscopicity: Slightly hygroscopic
Pharmaceutical Performance
Bioavailability: IV administration
Protein Binding: Low (<10%)
Half-life: 0.5 hours
Mechanism: DNA methyltransferase inhibitor
Purity Specifications
Assay (HPLC): ≥99.0%
Related Substances: ≤1.0% total
Water Content: ≤0.5% (Karl Fischer)
Residue on Ignition: ≤0.1%
Stability Properties
Shelf Life: 3 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Store below 25°C
pH Stability: Stable in acidic conditions

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Decitabine superiority in oncology applications with exceptional DNA methyltransferase inhibition, bioavailability, and reproducibility across diverse therapeutic protocols.

DNMT Inhibition

IC50: 460 nM for DNMT1

Potent DNA demethylation activity
IV Administration

Suitable for intravenous delivery

Optimized for hospital settings
Stability Profile

Chemical stability: Excellent under storage conditions

Maintains potency for 3 years
Thermal Stability

Melting point: 155-158°C

Stable during pharmaceutical processing
Batch Reproducibility

Variation: ±0.2% between batches

Consistent therapeutic efficacy
Shelf Stability

3 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Prescription pharmaceutical ingredient requiring professional handling. Cytotoxic agent with established safety profile for oncology therapy. Handle with pharmaceutical-grade safety precautions and ensure proper GMP environmental controls. Clinical monitoring required during therapeutic use.

Prescription Only
Cytotoxic Agent
Myelosuppression Risk

Storage & Handling

Store in original containers in a cool, dry, well-ventilated area away from moisture and light. Keep containers tightly closed and maintain pharmaceutical-grade environmental controls. Use appropriate cytotoxic handling techniques for API processing.

Cool storage (15-25°C)
Protect from moisture
Protect from light
Cytotoxic handling protocols

Chemical Mechanisms & Reaction Pathways

Decitabine exhibits antineoplastic properties through DNA methyltransferase inhibition and incorporation into DNA, enabling predictable anticancer effects with well-characterized pharmacokinetic and pharmacodynamic profiles.

Mechanism of Action

DNA methyltransferase inhibition with DNA incorporation

Epigenetic cancer therapy
Metabolic Pathway

Cytidine deaminase metabolism to inactive metabolites

Rapid enzymatic degradation
Pharmacokinetics

Intravenous administration with short half-life

Multi-day treatment cycles
Elimination

Rapid metabolism with renal excretion

Dose-dependent myelosuppression

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical market access with complete documentation packages supporting international drug registration and regulatory submissions.

USP Monograph

United States Pharmacopeia specifications compliance

EP Standards

European Pharmacopoeia monograph requirements

cGMP Manufacturing

Current Good Manufacturing Practices compliance

ICH Guidelines

International Council for Harmonisation standards

DMF Support

Drug Master File documentation assistance

Audit Readiness

Regulatory inspection preparation and support

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, regulatory guidance, and technical services to optimize Decitabine performance in your specific pharmaceutical applications.

Formulation Development
  • Excipient compatibility studies
  • Stability testing protocols
  • Dissolution optimization
  • Bioavailability enhancement
Analytical Services
  • Method validation support
  • Impurity identification
  • Stability indicating methods
  • Pharmaceutical testing
Technical Support
  • Regulatory compliance guidance
  • Quality assurance protocols
  • Manufacturing process support
  • Documentation preparation
Supply Solutions
  • Pharmaceutical grade scheduling
  • Global regulatory shipping
  • Custom packaging options
  • Emergency supply protocols

Environmental Impact & Sustainability

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

Waste Minimization

Optimized synthesis with minimal pharmaceutical waste

Water Treatment

Advanced wastewater treatment and recycling systems

Clean Production

Energy-efficient synthesis with emission controls

Safe Disposal

Pharmaceutical waste management guidance

ISO 14001

Environmental management system certification

Green Chemistry

Sustainable pharmaceutical synthesis methods

Manufacturing Excellence & Quality Control

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

cGMP Production

Current Good Manufacturing Practices in controlled pharmaceutical environment

FDA and WHO-GMP certified facility
Quality Testing

Comprehensive pharmaceutical testing including identity, purity, and potency

USP/EP monograph compliance verification
Quality Systems

ISO 9001:2015 with pharmaceutical quality management

Continuous improvement and validation
Packaging Control

Pharmaceutical-grade packaging with moisture protection

Stability and contamination prevention

Market Applications & Performance Data

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

Pharmaceutical Formulations
Bioavailability: Intravenous administration Half-life: 0.5-hour plasma clearance Stability: Freshly prepared infusion
Clinical Applications
Efficacy: Myelodysplastic syndrome treatment Safety: Myelosuppression monitoring Dosage: 15mg/m² IV for 3 days
Manufacturing Data
Purity: >99.5% pharmaceutical grade Consistency: ±0.3% batch variation Yield: >95% synthesis efficiency

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Consistently exceeds USP/EP specifications with exceptional pharmaceutical quality and performance

Reliable Supply

Guaranteed pharmaceutical-grade availability with cGMP production scheduling

Development Expertise

Dedicated pharmaceutical development team providing formulation and regulatory support

Quality Assurance

Comprehensive COA with pharmaceutical testing and regulatory compliance documentation

Global Standards

International compliance with USP, EP, and ICH guidelines for worldwide market access

Partnership Approach

Collaborative relationships with pharmaceutical companies and custom API development