Daunorubicin Hydrochloride USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Daunorubicin Hydrochloride USP/EP

High-purity pharmaceutical grade Daunorubicin Hydrochloride manufactured under stringent cGMP conditions. This anthracycline antibiotic API is essential for oncology applications, particularly in acute leukemia 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: C27H29NO10·HCl
CAS Number: 23541-50-6
Molecular Weight: 563.99 g/mol
Purity (HPLC): ≥98.0% (pharmaceutical grade)
Physical State: Red to orange crystalline powder
Water Content (Karl Fischer): ≤1.0%
Residue on Ignition: ≤0.2%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤2.0% total impurities
Storage Conditions: Store in cool, dry place (2-8°C)
Packaging Options: 100mg, 500mg pharmaceutical vials

Applications

Oncology Drug Manufacturing
Leukemia Treatment Formulations
Injectable Pharmaceutical Products
API Synthesis & Development
Anthracycline Research
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 Daunorubicin 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: ≤1.0% Heavy Metals: ≤10 ppm Application: Pharmaceutical formulations
EP Grade (European Pharmacopoeia)
Purity: ≥98.0% (pharmaceutical) Related Substances: ≤2.0% Residue on Ignition: ≤0.2% Application: European market compliance
Research Grade
Purity: ≥97.0% (analytical) Water Content: ≤2.0% Particle Size: Controlled Application: R&D, method development
GMP Grade
Purity: ≥99.0% (pharmaceutical) Endotoxins: ≤2.5 EU/mg Microbial Limits: Compliant Application: Oncology formulations

Quality Standards

DRAVYOM's pharmaceutical grade Daunorubicin 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 Daunorubicin 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): 0.8
pKa: 8.4
Molecular Weight: 563.99 g/mol
Physical Properties
Appearance: Red crystalline powder
Melting Point: 190-195°C (decomp.)
Bulk Density: 0.5-0.7 g/mL
Hygroscopicity: Hygroscopic
Pharmaceutical Performance
Bioavailability: IV administration
Protein Binding: 75%
Half-life: 18.5 hours
Mechanism: DNA intercalation, topoisomerase II inhibition
Purity Specifications
Assay (HPLC): ≥98.0%
Related Substances: ≤2.0% total
Water Content: ≤3.0% (Karl Fischer)
Residue on Ignition: ≤0.2%
Stability Properties
Shelf Life: 2 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Store 2-8°C
pH Stability: Stable at pH 4-7

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Daunorubicin Hydrochloride superiority in oncology applications with exceptional DNA intercalation, bioavailability, and reproducibility across diverse therapeutic protocols.

DNA Intercalation

High affinity for DNA binding

Potent cytotoxic activity against cancer cells
Topoisomerase Inhibition

Effective topoisomerase II inhibition

Prevents DNA repair mechanisms
Stability Profile

Chemical stability: Good under refrigerated storage

Maintains potency for 2 years
Thermal Stability

Decomposition: >190°C

Stable during pharmaceutical processing
Batch Reproducibility

Variation: ±0.3% between batches

Consistent therapeutic efficacy
Shelf Stability

2 years under proper refrigerated storage

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
Cardiotoxicity Risk

Storage & Handling

Store in original containers in a refrigerated environment (2-8°C) away from 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 light
Cytotoxic handling protocols
GMP handling required

Chemical Mechanisms & Reaction Pathways

Daunorubicin Hydrochloride exhibits antineoplastic properties through DNA intercalation and topoisomerase II inhibition, enabling predictable anticancer effects with well-characterized pharmacokinetic and pharmacodynamic profiles.

Mechanism of Action

DNA intercalation with topoisomerase II inhibition

Cancer cell growth inhibition
Metabolic Pathway

Hepatic metabolism to daunorubicinol via aldo-keto reductase

Active metabolite formation
Pharmacokinetics

Intravenous administration with tissue distribution

Multi-dose regimen
Elimination

Biliary excretion with hepatic metabolism

Dose-limiting cardiotoxicity

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 Daunorubicin Hydrochloride 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 Daunorubicin Hydrochloride 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 Daunorubicin Hydrochloride 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 Daunorubicin Hydrochloride effectiveness across diverse therapeutic applications with quantified performance metrics and clinical validation.

Pharmaceutical Formulations
Bioavailability: Intravenous administration Half-life: 18-hour plasma clearance Stability: 2+ years refrigerated storage
Clinical Applications
Efficacy: Acute leukemia treatment Safety: Cardiotoxicity monitoring Dosage: 25-45mg/m² IV
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