Methotrexate API
Pharmaceutical Oncology
Oncology API

Methotrexate

High-purity pharmaceutical grade Methotrexate API manufactured to meet stringent USP/EP specifications for cancer and autoimmune disease formulations. Our pharmaceutical grade API delivers exceptional purity and consistency for critical 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: C20H22N8O5
CAS Number: 59-05-2
EINECS Number: 200-413-8
Molecular Weight: 454.44 g/mol
Physical State: Bright yellow to orange crystalline powder
Purity (HPLC): ≥99.0% (USP/EP Grade)
Melting Point: 185-204°C (decomposes)
pH (1% solution): 6.0-7.5
Loss on Drying: ≤8.5%
Residue on Ignition: ≤0.2%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤2.0% (total impurities)
Storage Conditions: Store at room temperature, protect from light
Shelf Life: 3 years from date of manufacture
Packaging Options: 100g, 500g, 1kg pharmaceutical containers

Applications

Injectable Chemotherapy
Oral Tablet Formulations
Rheumatoid Arthritis Treatment
Autoimmune Disease Therapy
Oncology Research
Hospital Oncology Units
Specialty Pharmaceutical Manufacturing
Prescription Medications
Folate Antagonist Research
Clinical Trials
Regulatory Submissions
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Methotrexate grades tailored for specific oncology and rheumatology pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse drug manufacturing applications.

USP Grade (United States Pharmacopeia)
Purity: ≥99.0% (HPLC) Related Substances: ≤2.0% Heavy Metals: ≤10 ppm Application: FDA-compliant formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% (HPLC) Impurities: Individual ≤0.5% Loss on Drying: ≤8.5% Application: EU regulatory submissions
Oncology Research Grade
Purity: ≥99.5% (HPLC) Water Content: ≤0.2% Residue on Ignition: ≤0.1% Application: Cancer research studies
Reference Standard Grade
Purity: ≥99.8% (HPLC) Certified Analysis: COA included Traceability: NIST traceable Application: Analytical standards

Quality Standards

DRAVYOM's Methotrexate API is manufactured under stringent quality control protocols, meeting international pharmaceutical standards including USP, EP, and cGMP specifications. Our pharmaceutical-grade production ensures consistent performance and regulatory compliance.

cGMP Certified Manufacturing
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Analytical Testing
Ultra-Low Impurity Levels
Batch-to-Batch Consistency
Comprehensive Certificate of Analysis
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Methotrexate exhibits exceptional pharmaceutical properties essential for chemotherapy and immunosuppressive applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and cancer treatment protocols.

Pharmaceutical Properties
Molecular Weight: 454.44 g/mol
Solubility (Water): Slightly soluble
Partition Coefficient: LogP = -1.85
Bioavailability: Variable, dose-dependent
Physical Properties
Melting Point: 185-204°C
Appearance: Yellow-orange crystalline powder
Crystalline Form: Stable polymorphic form
Bulk Density: 0.25-0.45 g/mL
Formulation Performance
Dissolution Rate: ≥80% in 30 minutes
Tablet Hardness: 3-6 kp compatible
Compressibility: Good with proper excipients
Flow Properties: Fair to good
Purity Specifications
Total Impurities: ≤1.0%
Related Substances: ≤0.5% individual
Heavy Metals: ≤10 ppm
Residual Solvents: ICH Q3C compliant
Stability Properties
Shelf Life: 3 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Store 15-30°C
Humidity Sensitivity: Store below 60% RH

Performance Characteristics

Detailed performance metrics demonstrate Methotrexate superiority in pharmaceutical applications with exceptional efficacy, stability, and reproducibility across diverse formulation types and therapeutic protocols.

Therapeutic Performance

Bioavailability: Variable, dose-dependent

Excellent antineoplastic efficacy
Dissolution Rate

Release: ≥80% in 30 minutes

Consistent drug release profile
Analytical Performance

Purity: ≥99.0% HPLC

Superior analytical precision
Stability Performance

Shelf life: 3 years under proper storage

Extended pharmaceutical integrity
Batch Reproducibility

Variation: ±1.0% between batches

Exceptional lot-to-lot consistency
Processing Performance

Compressibility: Good with proper excipients

Superior manufacturing efficiency

Safety Information

HAZARDOUS: Cytotoxic pharmaceutical material requiring specialized handling procedures. Use containment protocols, protective equipment, and trained personnel experienced with cytotoxic agents. Follow all applicable regulatory guidelines for cytotoxic pharmaceutical manufacturing and handling.

Cytotoxic Material
Specialized Containment Required
cGMP Compliance

Storage & Handling

Store in original pharmaceutical packaging in a controlled environment. Maintain temperature and humidity conditions as specified and protect from light. Use specialized cytotoxic handling equipment and ensure proper documentation for pharmaceutical traceability and regulatory compliance.

Controlled temperature (15-30°C)
Protect from light
Cytotoxic containment protocols
Complete documentation required

Chemical Mechanisms & Reaction Pathways

Methotrexate exhibits potent antineoplastic and immunosuppressive activity through folate antagonism and DNA synthesis inhibition, enabling precise oncological applications with selective cellular targeting and anti-inflammatory properties.

Dihydrofolate Reductase Inhibition

Competitive inhibition of dihydrofolate reductase enzyme

Blocks folate synthesis and DNA replication
DNA Synthesis Disruption

Prevents thymidine and purine synthesis

Selectively targets rapidly dividing cells
Immunosuppression

Inhibits T-cell activation and proliferation

Anti-inflammatory and immunomodulatory effects
Polyglutamation

Intracellular conversion to polyglutamate forms

Enhanced cellular retention and activity

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical access with complete documentation packages supporting international standards and oncology drug development validations.

USP Specifications

United States Pharmacopeia oncology pharmaceutical grade standards compliance

EP Standards

European Pharmacopoeia specifications for antimetabolite pharmaceutical manufacturing

cGMP Manufacturing

Current Good Manufacturing Practice certified cytotoxic production facility

ICH Guidelines

International Conference on Harmonisation oncology quality standards

DMF Support

Drug Master File documentation for oncology regulatory submissions

Safety Documentation

Complete cytotoxic safety and handling documentation package

Technical Support & Value-Added Services

DRAVYOM's oncology pharmaceutical development team provides comprehensive formulation support, cytotoxic handling guidance, and regulatory support to optimize Methotrexate performance in your oncology pharmaceutical applications.

Formulation Development
  • Injectable formulation optimization
  • Tablet formulation design
  • Bioavailability optimization guidance
  • Stability enhancement strategies
Analytical Services
  • Certificate of Analysis verification
  • Cytotoxic impurity profiling
  • Stability method validation
  • Specialized testing programs
Technical Support
  • Cytotoxic handling consultation
  • cGMP compliance for oncology APIs
  • Containment system design
  • Regulatory documentation support
Supply Solutions
  • Specialized cytotoxic packaging
  • Light-protected logistics
  • Emergency oncology supply
  • Global pharmaceutical distribution

Environmental Impact & Sustainability

Our Methotrexate production emphasizes environmental responsibility through sustainable cytotoxic pharmaceutical manufacturing practices, specialized waste management, and comprehensive environmental impact control for oncology operations.

Cytotoxic Waste Management

Specialized treatment and disposal of cytotoxic pharmaceutical waste

Wastewater Treatment

Advanced cytotoxic pharmaceutical wastewater treatment systems

Containment Systems

Closed-loop manufacturing with environmental protection

Resource Recovery

Solvent recovery and raw material optimization programs

ISO 14001

Environmental management system for cytotoxic production

Safe Transport

Specialized logistics minimizing environmental impact

Manufacturing Excellence & Quality Control

DRAVYOM's specialized cytotoxic pharmaceutical manufacturing facility employs advanced containment technology and continuous monitoring systems to ensure consistent Methotrexate quality and safety across all production batches.

Production Process

Contained synthesis and purification in specialized cytotoxic environment

Multi-barrier containment for operator and environmental protection
Quality Testing

Comprehensive analytical testing including cytotoxic impurity analysis

Specialized HPLC and mass spectrometry analysis
Quality Systems

ISO 9001:2015 with cytotoxic pharmaceutical manufacturing certification

Specialized quality systems for oncology APIs
Packaging Control

Specialized cytotoxic packaging with light protection

Light-resistant containers and controlled atmosphere packaging

Market Applications & Performance Data

Comprehensive oncology pharmaceutical development data demonstrating Methotrexate effectiveness across diverse therapeutic applications with quantified performance metrics and clinical development validations for cancer and autoimmune treatment.

Oncology Manufacturing
Bioavailability: Dose-dependent, 20-95% Stability: Light-protected storage required Purity: >99.0% pharmaceutical grade
Clinical Applications
Efficacy: Proven oncology and rheumatology treatment Safety: Established toxicity profile Regulatory: Oncology approvals worldwide
Manufacturing Capabilities
Capacity: Controlled production batches Consistency: <0.5% batch-to-batch variation Compliance: 100% cytotoxic cGMP adherence

DRAVYOM Competitive Advantages

Cytotoxic Expertise

Specialized cytotoxic manufacturing with ultra-low impurities and exceptional oncology pharmaceutical performance

Reliable Supply

Guaranteed availability with specialized inventory management and oncology-grade production scheduling

Oncology Expertise

Dedicated oncology pharmaceutical development team with cytotoxic formulation expertise

Quality Assurance

Comprehensive certificates with complete analytical data and cytotoxic handling documentation

Global Standards

International compliance with USP, EP, and ICH specifications for worldwide oncology pharmaceutical acceptance

Partnership Approach

Collaborative relationships with oncology pharmaceutical companies and custom cytotoxic API development