Valrubicin Hydrochloride USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Valrubicin Hydrochloride USP/EP

High-purity pharmaceutical grade Valrubicin Hydrochloride manufactured under stringent cGMP conditions. This anthracycline antineoplastic API is essential for oncology applications, particularly in bladder cancer intravesical therapy, providing reliable quality and regulatory compliance.

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

Chemical Formula: C34H36NO13·HCl
CAS Number: 72496-41-4
Molecular Weight: 723.11 g/mol
Physical State: Red-orange crystalline powder
Purity (HPLC): ≥98.0% (USP/EP Grade)
Loss on Drying: ≤3.0%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤2.0% (total impurities)
Storage Conditions: Store at 2-8°C, protect from light
Shelf Life: 3 years from date of manufacture
Packaging Options: 10mg, 25mg, 50mg vials

Applications

Intravesical Therapy
Bladder Cancer Treatment
Oncology Formulations
Anthracycline Therapy
Cancer Research
Clinical Studies

Industry-Specific Grades

DRAVYOM offers specialized Valrubicin Hydrochloride grades tailored for specific oncology pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse cancer treatment applications.

USP Grade (United States Pharmacopeia)
Purity: ≥98.0% (HPLC) Related Substances: ≤2.0% Heavy Metals: ≤10 ppm Application: FDA-compliant oncology formulations
EP Grade (European Pharmacopoeia)
Purity: ≥98.0% (HPLC) Loss on Drying: ≤3.0% Chloride: ≤0.5% Application: EU regulatory submissions
Clinical Grade
Purity: ≥99.0% (HPLC) Endotoxin: ≤0.25 EU/mg Sterility: Compliant Application: Clinical trials
Research Grade
Purity: ≥97.0% (HPLC) Activity: Confirmed Documentation: Research COA Application: Preclinical research

Quality Standards

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

ISO 9001:2015 Certified Manufacturing
USP/EP Grade Specifications
≥98.0% HPLC Purity
Advanced Oncology Testing
Cold Chain Storage
Comprehensive COA
Temperature-Controlled Logistics
Batch-to-Batch Consistency

Advanced Chemical Properties & Performance

Pharmaceutical Grade Valrubicin Hydrochloride exhibits exceptional chemical properties essential for oncology applications. Its anthracycline antineoplastic composition and precise specification ensure reliable performance in demanding pharmaceutical formulations and cancer treatment systems.

Chemical Properties
Molecular Formula: C₃₄H₃₆NO₁₃·HCl
Molecular Weight: 723.15 g/mol
Melting Point: 118-122°C
LogP (Octanol/Water): 1.5
Physical Properties
Appearance: Orange-red crystalline powder
Solubility: Soluble in methanol, DMSO
pH (0.1% solution): 3.0-4.5
Hygroscopicity: Slightly hygroscopic
Pharmaceutical Performance
Bioavailability: Intravesical administration
Half-life: Variable (tissue-dependent)
Protein Binding: >99%
Mechanism: DNA intercalation/topoisomerase II
Purity Specifications
Assay (HPLC): ≥ 98.0%
Related Substances: ≤ 1.0%
Heavy Metals: ≤ 20 ppm
Residual Solvents: Within ICH limits
Stability Properties
Shelf Life: 2 years (unopened, refrigerated)
Photostability: Highly light sensitive
Temperature Stability: Store 2-8°C
Humidity Stability: Store ≤60% RH

Performance Characteristics

Detailed performance metrics demonstrate Pharmaceutical Grade Valrubicin Hydrochloride superiority in oncology applications with exceptional functionality, stability, and reproducibility across diverse pharmaceutical procedures and cancer treatment protocols.

Antineoplastic Efficacy

Potency: DNA intercalating anthracycline

Superior cytotoxic activity
Intravesical Retention

Time: Extended bladder residence

Targeted tumor exposure
Local Delivery

Route: Intravesical instillation

Minimal systemic exposure
Formulation Stability

Range: Stable under refrigerated conditions

Maintained potency with cold storage
Batch Uniformity

Variation: ±1.0% between production batches

Consistent pharmaceutical grade quality
Long-term Stability

2 years shelf life with cold chain

Extended pharmaceutical grade integrity

Safety Information

Potent cytotoxic agent requiring specialized handling and administration. Oncology-specific pharmaceutical for bladder cancer treatment. Handle with extreme caution using appropriate protective equipment and containment procedures. Store under refrigerated conditions and protect from light. Requires oncology-trained personnel for handling and preparation.

Cytotoxic Agent
Specialized Handling
Hospital Use Only

Storage & Handling

Store in original sealed containers in refrigerated conditions (2-8°C) in a well-ventilated area with complete light protection. Use specialized cytotoxic handling procedures with appropriate containment systems. Requires trained oncology personnel and proper disposal protocols for contaminated materials.

Refrigerated storage (2-8°C)
Complete light protection
Cytotoxic handling protocols
Specialized disposal required

Chemical Mechanisms & Reaction Pathways

Pharmaceutical Grade Valrubicin Hydrochloride exhibits potent anthracycline antineoplastic properties through DNA intercalation mechanisms enabling effective bladder cancer treatment with reduced systemic toxicity compared to doxorubicin.

DNA Intercalation

Intercalation between DNA base pairs disrupting replication

Primary mechanism for antineoplastic activity
Topoisomerase Inhibition

Inhibition of topoisomerase II enzyme complex

Prevents DNA strand separation and repair
Cell Cycle Arrest

G2/M phase cell cycle arrest leading to apoptosis

Selective targeting of rapidly dividing cancer cells
Reduced Cardiotoxicity

Modified structure reduces cardiac accumulation

Improved safety profile versus traditional anthracyclines

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical market access with complete API documentation supporting international standards and oncology drug manufacturing validations.

USP Specifications

United States Pharmacopeia API standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical manufacturing

FDA Approved

FDA approved oncology API with comprehensive safety data

EMA Approval

European Medicines Agency approval for oncology applications

DMF Documentation

Drug Master File with comprehensive manufacturing and safety data

cGMP Certified

Current Good Manufacturing Practice with oncology API standards

Technical Support & Value-Added Services

DRAVYOM's oncology API team provides comprehensive development support, formulation optimization assistance, and regulatory services for antineoplastic drug manufacturing with specialized oncology expertise.

API Development
  • Oncology formulation support
  • Stability optimization studies
  • Intravesical delivery development
  • Analytical method development
Analytical Services
  • Certificate of Analysis with oncology testing
  • Polymorphic form characterization
  • Impurity profiling and identification
  • Stability study support
Regulatory Support
  • Oncology drug documentation
  • Regulatory filing assistance
  • Clinical trial support
  • Post-market surveillance
Secure Supply
  • Controlled API supply chains
  • Temperature-controlled logistics
  • Enhanced security protocols
  • Global distribution network

Environmental Impact & Sustainability

Our Pharmaceutical Grade Valrubicin Hydrochloride production emphasizes environmental responsibility through green chemistry principles, sustainable synthetic pathways, and comprehensive environmental impact management for API manufacturing.

Green Synthesis

Optimized synthetic routes with minimal environmental impact

Solvent Recovery

Advanced solvent recycling and waste minimization

Clean Production

Energy-efficient synthesis with emission controls

Water Treatment

Advanced wastewater treatment and recycling systems

ISO 14001

Environmental management system certified production

Safe Disposal

Specialized cytotoxic waste management protocols

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art oncology API manufacturing facility employs advanced containment technology and continuous monitoring systems to ensure consistent Pharmaceutical Grade Valrubicin Hydrochloride quality and safety.

Contained Production

High-containment manufacturing with enhanced safety protocols

Cytotoxic API production with environmental protection
Quality Testing

29-point pharmaceutical testing protocol including potency analysis

HPLC verification and oncology-specific testing
Quality Systems

cGMP compliance with oncology API manufacturing standards

Enhanced safety and quality protocols
Secure Packaging

Specialized packaging with light and moisture protection

Containment and stability maintenance

Market Applications & Performance Data

Comprehensive clinical and pharmaceutical data demonstrating Pharmaceutical Grade Valrubicin Hydrochloride effectiveness in bladder cancer applications with quantified therapeutic metrics and safety profiles.

Bladder Cancer
Efficacy: 21% complete response rate Recurrence: Delayed tumor recurrence Local Therapy: Intravesical administration
Safety Profile
Systemic: Minimal systemic absorption Cardiotoxicity: Reduced cardiac risk Local Tolerance: Manageable bladder irritation
Clinical Benefits
BCG Failures: Option for BCG-refractory cases Cystectomy Alternative: Bladder-sparing approach Quality of Life: Preserved organ function

DRAVYOM Competitive Advantages

Superior Purity

Consistently exceeds pharmacopeial specifications with optimal chemical stability and impurity control

Reliable Supply

Guaranteed availability with strategic inventory management and oncology API expertise

API Expertise

Specialized oncology API manufacturing with comprehensive cytotoxic handling protocols

Quality Assurance

Enhanced testing protocols with complete documentation and regulatory compliance

Global Standards

International compliance with USP, EP, and oncology drug regulations worldwide

Partnership Approach

Collaborative relationships with oncology pharmaceutical companies and specialized development support