Epirubicin Hydrochloride USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Epirubicin Hydrochloride USP/EP

High-purity pharmaceutical grade Epirubicin Hydrochloride manufactured under stringent cGMP conditions. This anthracycline antibiotic API is essential for oncology applications, particularly in breast cancer treatment, providing reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical API
  • cGMP Manufacturing Standards
  • ≥98.0% Purity (HPLC)
  • Comprehensive COA Documentation
  • Anthracycline Antibiotic for Oncology
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: C27H29NO11·HCl
CAS Number: 56420-45-2
Molecular Weight: 579.98 g/mol
Purity (HPLC): ≥98.0% (pharmaceutical grade)
Physical State: Red-orange crystalline powder
Water Content (Karl Fischer): ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤2.0% total impurities
Storage Conditions: Store in cool, dry place (2-8°C)
Packaging Options: 10mg, 50mg pharmaceutical vials

Applications

Cancer Chemotherapy Manufacturing
Anthracycline Antibiotic
Injectable Pharmaceutical Products
API Synthesis & Development
Breast Cancer 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 Epirubicin Hydrochloride grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse oncology drug manufacturing applications.

USP Grade (Pharmaceutical)
Purity: ≥98.0% (HPLC) Water Content: ≤0.5% Heavy Metals: ≤10 ppm Application: Pharmaceutical formulations
EP Grade (European Pharmacopoeia)
Purity: ≥98.0% (pharmaceutical) Related Substances: ≤2.0% Residue on Ignition: ≤0.1% Application: European market compliance
Research Grade
Purity: ≥95.0% (analytical) Water Content: ≤1.0% Particle Size: Controlled Application: R&D, method development
GMP Grade
Purity: ≥98.5% (pharmaceutical) Endotoxins: ≤2.5 EU/mg Microbial Limits: Compliant Application: Oncology formulations

Quality Standards

DRAVYOM's pharmaceutical grade Epirubicin Hydrochloride 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
≥98.0% Pharmaceutical Purity
Advanced Analytical Testing
Comprehensive Impurity Control
Batch-to-Batch Consistency
Complete Documentation Package
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Pharmaceutical grade Epirubicin Hydrochloride 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): Freely soluble
LogP (octanol/water): -1.2
pKa: 8.0
Molecular Weight: 579.98 g/mol
Physical Properties
Appearance: Red-orange crystalline powder
Melting Point: 200-202°C (with decomposition)
Bulk Density: 0.4-0.6 g/mL
Hygroscopicity: Hygroscopic
Pharmaceutical Performance
Bioavailability: IV administration only
Protein Binding: 77%
Half-life: 33 hours
Mechanism: DNA intercalation, topoisomerase II inhibitor
Purity Specifications
Assay (HPLC): ≥98.5%
Related Substances: ≤0.5% total
Water Content: ≤2.0% (Karl Fischer)
Residue on Ignition: ≤0.1%
Stability Properties
Shelf Life: 3 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Store at 2-8°C
pH Stability: Stable in acidic conditions

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Epirubicin Hydrochloride superiority in oncology applications with exceptional DNA intercalation, topoisomerase II inhibition, and reproducibility across diverse therapeutic protocols.

DNA Intercalation

Potent DNA binding and intercalation

Disrupts DNA replication
Topoisomerase II Inhibition

Inhibits DNA topoisomerase II

Prevents DNA repair
Stability Profile

Chemical stability: Excellent under storage conditions

Maintains potency for 3 years
Thermal Stability

Decomposition: 200-202°C

Stable during pharmaceutical processing
Batch Reproducibility

Variation: ±0.1% between batches

Consistent therapeutic efficacy
Reduced Cardiotoxicity

Lower cardiotoxicity compared to doxorubicin

Safer oncology profile

Safety Information

Cytotoxic pharmaceutical ingredient requiring specialized handling protocols. Well-established safety profile for oncology therapy. Handle with extreme caution using appropriate cytotoxic safety precautions and ensure proper GMP environmental controls. Clinical monitoring for cardiotoxicity and myelosuppression.

Cytotoxic
Professional Use
Monitor cardiac function

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.

Refrigerated storage (2-8°C)
Protect from moisture (hygroscopic)
Protect from light
Cytotoxic handling required

Chemical Mechanisms & Reaction Pathways

Epirubicin Hydrochloride exhibits cytotoxic and antineoplastic properties through DNA intercalation and topoisomerase II inhibition, disrupting cancer cell replication and inducing apoptosis with reduced cardiotoxicity compared to doxorubicin.

DNA Intercalation

Inserts between DNA base pairs disrupting structure

Prevents DNA replication and transcription
Topoisomerase II Inhibition

Prevents DNA unwinding and strand separation

Blocks cell cycle progression
Reduced Cardiotoxicity

Lower cardiac toxicity profile than doxorubicin

Safer anthracycline alternative
Apoptosis Induction

Activates programmed cell death pathways

Selective cancer cell targeting

Regulatory Compliance & Documentation

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

USP Standards

United States Pharmacopeia oncology drug specifications

EP Monograph

European Pharmacopoeia specifications for anthracyclines

Cytotoxic GMP

Specialized GMP for cytotoxic drug manufacturing

ICH Guidelines

International oncology drug development regulatory compliance

Oncology DMF

Drug Master File for oncology applications

Cytotoxic Safety

Comprehensive cytotoxic handling and safety documentation

Technical Support & Value-Added Services

DRAVYOM's oncology pharmaceutical team provides comprehensive formulation support, stability testing, and regulatory services for Epirubicin Hydrochloride oncology applications.

Oncology Formulation
  • Anthracycline formulation optimization
  • Stability testing for oncology drugs
  • Bioavailability enhancement
  • Custom oncology development
Oncology Analytics
  • Cytotoxic API purity analysis
  • Anthracycline impurity profiling
  • Specialized testing services
  • Oncology method validation
Regulatory Support
  • Oncology regulatory filing
  • Cytotoxic DMF preparation
  • International compliance guidance
  • Oncology pharmacovigilance
Specialized Supply
  • Cytotoxic supply chain management
  • Specialized packaging solutions
  • Cold chain distribution
  • Emergency oncology supply

Environmental Impact & Sustainability

Our Epirubicin Hydrochloride production emphasizes environmental responsibility through sustainable cytotoxic manufacturing practices, specialized waste management, and environmental impact control.

Specialized Waste

Cytotoxic waste treatment and disposal protocols

Water Treatment

Advanced wastewater treatment for cytotoxic manufacturing

Clean Production

Contained manufacturing processes with emission controls

Environmental Safety

Comprehensive environmental protection protocols

ISO 14001

Environmental management for pharmaceutical manufacturing

Sustainable Sourcing

Responsible procurement of raw materials

Manufacturing Excellence & Quality Control

DRAVYOM's specialized cytotoxic manufacturing facility employs advanced containment technology and continuous monitoring systems to ensure consistent Epirubicin Hydrochloride quality and safety.

Cytotoxic GMP

Specialized containment manufacturing in controlled environment

Multi-stage purification with cytotoxic safety
Oncology Testing

Comprehensive testing including potency, purity, and safety

HPLC and specialized oncology analytics
Quality Systems

ISO 9001:2015 with specialized cytotoxic protocols

Continuous improvement and oncology validation
Specialized Packaging

Cytotoxic-grade containers with refrigeration requirements

Cold chain and contamination prevention

Market Applications & Performance Data

Comprehensive oncology data demonstrating Epirubicin Hydrochloride effectiveness in cancer treatment with quantified performance metrics and clinical validation data.

Oncology Formulations
Bioavailability: 95-98% IV administration Stability: 2-year refrigerated shelf life Potency: Consistent cytotoxic activity
Clinical Applications
Oncology: Proven anticancer efficacy Cardiotoxicity: Reduced cardiac toxicity Safety: Improved tolerability profile
Manufacturing Performance
Yield: 96% pharmaceutical grade recovery Purity: >99% cytotoxic specification Consistency: 99.8% batch-to-batch reproducibility

DRAVYOM Competitive Advantages

Oncology Excellence

Superior cytotoxic pharmaceutical grade with proven anticancer performance and regulatory compliance

Reliable Supply

Guaranteed cytotoxic supply with specialized inventory management and oncology production scheduling

Oncology Expertise

Dedicated oncology development team with specialized cytotoxic formulation support

Regulatory Compliance

Complete oncology documentation with specialized DMF and international compliance

Global Standards

International oncology compliance with USP, EP, and ICH cytotoxic guidelines

Partnership Approach

Collaborative oncology relationships with specialized cytotoxic development services