Pomalidomide API
Pharmaceutical Oncology
Oncology API

Pomalidomide

High-purity pharmaceutical grade Pomalidomide API manufactured to meet stringent USP/EP specifications for targeted cancer therapy 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
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Technical Specifications

Chemical Formula: C13H11N3O4
CAS Number: 19171-19-8
EINECS Number: 242-934-5
Purity (HPLC): ≥99.0% (USP/EP Grade)
Physical State: White to off-white crystalline powder
Molecular Weight: 273.24 g/mol
Melting Point: 270-275°C
pH (1% solution): 5.5-7.5
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals: ≤10 ppm
Solubility: Practically insoluble in water
Storage Conditions: Store at 2-8°C, protect from light
Shelf Life: 3 years from manufacture date
Packaging Options: 1g, 5g, 25g vials

Applications

Multiple Myeloma
Refractory Multiple Myeloma
Oral Capsule Formulations
Immunomodulatory Therapy
Tablet Preparations
Anti-angiogenic Activity
Targeted Hematology Therapy
Combination Therapy
Oncology Research
Clinical Trials
Cancer Drug Development
Regulatory Studies

Industry-Specific Grades

DRAVYOM offers specialized Pomalidomide grades tailored for specific oncology applications, ensuring optimal immunomodulatory efficacy and regulatory compliance across diverse cancer treatment formulations.

USP Grade (United States Pharmacopoeia)
Purity: ≥99.0% Water Content: ≤0.5% Heavy Metals: ≤10 ppm Application: FDA approved formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% Related Substances: ≤1.0% Residual Solvents: EP limits Application: European market compliance
Research Grade
Purity: ≥98.0% Activity: Verified Stability: Enhanced Application: Hematology research
Oral Formulation Grade
Purity: ≥99.5% Particle Size: Controlled Bioavailability: Optimized Application: Oral dosage forms

Quality Standards

DRAVYOM's Pomalidomide is manufactured under stringent cGMP protocols, meeting international oncology drug standards including USP, EP, and FDA guidelines for immunomodulatory therapy applications.

cGMP Manufacturing Standards
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Analytical Testing
Immunomodulatory Activity Verified
Batch-to-Batch Consistency
Comprehensive COA Documentation
Cold Chain Storage & Shipping

Advanced Chemical Properties & Performance

Pharmaceutical Grade Pomalidomide exhibits exceptional chemical properties essential for oncology applications. Its potent immunomodulatory structure and superior stability characteristics ensure reliable performance in demanding multiple myeloma therapy formulations.

Molecular Properties
Molecular Weight: 273.24 g/mol
Molecular Formula: C13H11N3O4
LogP (Octanol/Water): -0.5
pKa: 9.2
Physical Properties
Melting Point: 247-251°C
Appearance: White to off-white crystalline powder
Solubility (Water): Slightly soluble
Bulk Density: 0.50-0.60 g/cm³
Pharmaceutical Properties
Bioavailability: 73%
Protein Binding: 12-44%
Half-life: 9.5 hours
Mechanism: Immunomodulatory, anti-angiogenic
Quality Specifications
Purity (HPLC): ≥99.0%
Water Content: ≤0.5%
Related Substances: ≤1.0%
Heavy Metals: ≤10 ppm
Stability Properties
Shelf Life: 3 years (unopened)
Storage Temperature: 15-25°C
Light Sensitivity: Store in light-resistant containers
Moisture Sensitivity: Store in dry conditions

Performance Characteristics

Detailed performance metrics demonstrate Pomalidomide superiority in oncology applications with exceptional immunomodulation, anti-angiogenic activity, and therapeutic efficacy across diverse multiple myeloma treatment protocols.

Immunomodulation

Potent immune system activation and enhancement

Enhanced T-cell and NK cell activity
Anti-angiogenesis

Inhibition of tumor blood vessel formation

Reduced tumor vascularization
Multiple Myeloma Activity

Superior efficacy in relapsed/refractory multiple myeloma

Third-generation IMiD therapy
Rapid Onset

9.5-hour elimination half-life

Convenient daily dosing
Clinical Performance

FDA-approved for relapsed/refractory multiple myeloma

Proven hematological efficacy
Oral Bioavailability

Good oral absorption and tolerability

Patient-friendly administration

Safety Information

Highly potent immunomodulatory 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 cytotoxic compounds.

Highly Cytotoxic
Hazardous Drug
Containment Required

Storage & Handling

Store in tightly closed, light-resistant containers in a cool, dry place away from direct sunlight. Maintain controlled room temperature storage in secure areas with appropriate containment systems and access controls for cytotoxic compounds.

Controlled room temperature (15-25°C)
Secure containment required
Light-resistant containers
Hazardous drug protocols

Chemical Mechanisms & Reaction Pathways

Pomalidomide functions as a highly potent immunomodulatory drug with multi-target activity against multiple myeloma, providing effective treatment through cereblon binding, TNF-α inhibition, and direct cytotoxic effects on malignant plasma cells.

Cereblon Binding

High-affinity binding to cereblon E3 ubiquitin ligase

Induces protein degradation pathways
Immunomodulation

Enhanced T-cell and NK-cell cytotoxicity

Stimulates anti-tumor immunity
Anti-Angiogenesis

Inhibition of tumor angiogenesis and microenvironment

Reduces tumor vascularization
Direct Cytotoxicity

Direct apoptotic effects on myeloma cells

Multiple mechanisms of action

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical acceptance with complete documentation packages supporting international drug development and manufacturing requirements.

USP Specifications

United States Pharmacopeia pharmaceutical grade compliance

EP Standards

European Pharmacopoeia specifications and testing protocols

ICH Guidelines

International harmonized pharmaceutical development standards

Global Regulatory

Multi-regional pharmaceutical registration support

DMF Support

Drug Master File preparation and regulatory submission

GMP Compliance

Good Manufacturing Practice certified production

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, analytical method development, and regulatory assistance to optimize Pomalidomide performance in pharmaceutical applications.

Formulation Development
  • Capsule formulation optimization
  • Bioavailability enhancement
  • Stability improvement strategies
  • Dissolution profile optimization
Analytical Services
  • Method validation and transfer
  • Impurity profiling and identification
  • Stability testing programs
  • Cereblon binding assays
Regulatory Support
  • Regulatory strategy development
  • Documentation preparation
  • Regulatory submission support
  • Global compliance guidance
Supply Solutions
  • Reliable supply chain management
  • Controlled storage packaging
  • Emergency supply arrangements
  • Global distribution network

Environmental Impact & Sustainability

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

Green Chemistry

Environmentally conscious synthesis with minimal waste

Water Management

Advanced wastewater treatment and recycling systems

Energy Efficiency

Optimized manufacturing processes with reduced energy consumption

Waste Reduction

Comprehensive waste minimization and disposal protocols

ISO 14001

Environmental management system certified production

Carbon Footprint

Reduced environmental impact through sustainable practices

Manufacturing Excellence & Quality Control

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

GMP Production

Good Manufacturing Practice certified facility with controlled environments

Pharmaceutical-grade production standards
Quality Testing

Comprehensive analytical testing including potency and purity

HPLC, LC-MS, and cereblon assays
Quality Systems

ISO 9001:2015 quality management with pharmaceutical compliance

Continuous improvement and validation protocols
Packaging Control

Controlled atmosphere packaging with moisture protection

Stability maintenance and protection systems

Market Applications & Performance Data

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

Pharmaceutical Manufacturing
Bioavailability: >73% oral absorption Half-life: 9.5 hours elimination Purity: >99.5% pharmaceutical grade
Drug Development
Formulation Support: Multiple myeloma therapy Regulatory Success: Global approvals achieved Innovation: Immunomodulatory therapies
Clinical Applications
Efficacy: Cereblon-mediated activity Safety: Established oncology profile Specialization: Hematologic malignancies

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Consistently exceeds USP/EP specifications with pharmaceutical-grade quality and performance

Reliable Supply

Guaranteed availability with strategic inventory management and pharmaceutical-grade production

Development Expertise

Dedicated pharmaceutical team provides formulation development and regulatory support

Quality Assurance

Comprehensive documentation with pharmaceutical-grade certificates and regulatory compliance

Global Standards

International compliance with USP, EP, and ICH guidelines for worldwide acceptance

Partnership Approach

Collaborative relationships with pharmaceutical companies and custom development services