Pemetrexed Disodium API
Pharmaceutical Oncology
Oncology API

Pemetrexed Disodium

High-purity pharmaceutical grade Pemetrexed Disodium API manufactured to meet stringent USP/EP specifications for cancer chemotherapy 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: C20H19N5Na2O6
CAS Number: 150399-23-8
EINECS Number: Not applicable
Purity (HPLC): ≥99.0% (USP/EP Grade)
Physical State: White to light yellow lyophilized powder
Molecular Weight: 471.37 g/mol
Melting Point: Decomposes at >200°C
pH (1% solution): 6.0-8.0
Loss on Drying: ≤1.0%
Residue on Ignition: ≤0.2%
Heavy Metals: ≤10 ppm
Solubility: Freely soluble in water
Storage Conditions: Store at 2-8°C, protect from light
Shelf Life: 3 years from manufacture date
Packaging Options: 100mg, 500mg vials

Applications

Non-Small Cell Lung Cancer
Malignant Pleural Mesothelioma
Injectable Solutions
Antifolate Antimetabolite
IV Infusion Preparations
Folate Pathway Inhibition
Thymidine Synthesis Inhibitor
Combination Chemotherapy
Oncology Research
Clinical Trials
Cancer Drug Development
Regulatory Studies

Industry-Specific Grades

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

USP Grade (United States Pharmacopoeia)
Purity: ≥99.0% Water Content: ≤1.0% 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
Injectable Grade
Purity: ≥99.5% Sterility: Assured Endotoxins: <0.25 EU/mg Application: IV chemotherapy
Research Grade
Purity: ≥98.0% Activity: Verified Stability: Enhanced Application: Cancer research

Quality Standards

DRAVYOM's Pemetrexed Disodium is manufactured under stringent cGMP protocols, meeting international oncology drug standards including USP, EP, and FDA guidelines for cancer chemotherapy applications.

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

Advanced Chemical Properties & Performance

Pemetrexed Disodium exhibits exceptional antifolate properties essential for oncology applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding cancer treatment formulations.

Molecular Properties
Molecular Weight: 597.47 g/mol
LogP: -3.4
pKa: 3.6, 4.4
Bioavailability: 80%
Physical Properties
Melting Point: >300°C (decomposes)
Solubility (Water): 50 mg/mL
Crystalline Form: Stable disodium salt
Hygroscopicity: Hygroscopic
Pharmaceutical Performance
DHFR IC50: 1.3 nM
GARFT IC50: 65 nM
Selectivity: Multitarget antifolate
Stability: Stable in solution
Purity Specifications
Assay: ≥99.0%
Related Substances: ≤1.0%
Heavy Metals: ≤10 ppm
Residual Solvents: ICH Q3C compliant
Stability Properties
Shelf Life: 3 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Refrigerated storage
pH Stability: Stable pH 6-8

Performance Characteristics

Detailed performance metrics demonstrate Pemetrexed Disodium superiority in oncology applications with exceptional antifolate activity, bioavailability, and reproducibility across diverse cancer treatment formulations.

Antifolate Activity

IC50: 1.3 nM (DHFR), 65 nM (GARFT)

Potent multitarget inhibition
Bioavailability

IV: 80% plasma protein binding

Effective drug distribution
Stability

Solution: >3 years stability

Long-term pharmaceutical integrity
Thermal Stability

Working range: 2-8°C storage

Cold chain requirement
Batch Reproducibility

Variation: ±0.5% between batches

Consistent lot-to-lot performance
Shelf Stability

3 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Potent cytotoxic API requiring specialized handling. Handle with appropriate protective equipment in controlled environments. Avoid skin contact and inhalation. Follow cGMP guidelines for cytotoxic APIs and ensure proper waste disposal procedures.

Cytotoxic API
Avoid Skin Contact
Avoid Inhalation

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 cytotoxic API handling.

Refrigerated storage (2-8°C)
Protect from light
Original sealed containers
Cytotoxic containment required

Chemical Mechanisms & Reaction Pathways

Pemetrexed disodium functions as a multitargeted antifolate with potent antineoplastic activity through inhibition of multiple folate-dependent enzymes, providing effective cancer treatment with broad-spectrum cytotoxic activity.

Folate Pathway Inhibition

Multiple enzyme inhibition in folate metabolism

Disrupts DNA synthesis and repair
DHFR Inhibition

Dihydrofolate reductase enzyme inhibition

Blocks purine synthesis pathway
TS Inhibition

Thymidylate synthase pathway disruption

Prevents thymidine production
Cell Cycle Arrest

S-phase cell cycle checkpoint inhibition

Induces apoptosis in cancer cells

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 Pemetrexed disodium performance in pharmaceutical applications.

Formulation Development
  • Injectable formulation development
  • Lyophilization optimization
  • Stability enhancement strategies
  • Compatibility studies
Analytical Services
  • Method validation and transfer
  • Impurity profiling and identification
  • Stability testing programs
  • Antifolate activity assays
Regulatory Support
  • Regulatory strategy development
  • Documentation preparation
  • Regulatory submission support
  • Global compliance guidance
Supply Solutions
  • Reliable supply chain management
  • Cold chain packaging
  • Emergency supply arrangements
  • Global distribution network

Environmental Impact & Sustainability

Our Pemetrexed disodium 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 Pemetrexed disodium 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 folate enzyme assays
Quality Systems

ISO 9001:2015 quality management with pharmaceutical compliance

Continuous improvement and validation protocols
Packaging Control

Controlled atmosphere packaging with light protection

Stability maintenance and protection systems

Market Applications & Performance Data

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

Pharmaceutical Manufacturing
Bioavailability: >95% intravenous delivery Half-life: 3.5 hours elimination Purity: >99.5% pharmaceutical grade
Drug Development
Formulation Support: Injectable oncology products Regulatory Success: Global approvals achieved Innovation: Combination therapy development
Clinical Applications
Efficacy: Multitargeted antifolate activity Safety: Manageable side effect profile Specialization: Lung cancer treatment

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