Bendamustine Hydrochloride API
Pharmaceutical Oncology
Oncology API

Bendamustine Hydrochloride

High-purity pharmaceutical grade Bendamustine Hydrochloride API manufactured to meet stringent USP/EP specifications for cancer treatment 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: C16H21Cl2N3O2·HCl
CAS Number: 3543-75-7
Molecular Weight: 394.73 g/mol
Purity (HPLC): ≥99.0% (pharmaceutical grade)
Physical State: White to off-white crystalline powder
Water Content (Karl Fischer): ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% total impurities
Storage Conditions: Store in cool, dry place (2-8°C)
Packaging Options: 100mg, 1g pharmaceutical vials

Applications

Cancer Treatment Drug Manufacturing
Oncology Formulations
Injectable Pharmaceutical Products
API Synthesis & Development
Alkylating Agent Research
Pharmaceutical Research
Oncology Drug Manufacturing
Quality Control Testing
Regulatory Compliance
Clinical Trial Materials
Bioanalytical Method Development
Reference Standard Applications

Industry-Specific Grades

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

USP Grade (Pharmaceutical)
Purity: ≥99.0% (HPLC) Water Content: ≤0.5% Heavy Metals: ≤10 ppm Application: Pharmaceutical formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% (pharmaceutical) Related Substances: ≤1.0% Residue on Ignition: ≤0.1% Application: European market compliance
Research Grade
Purity: ≥98.0% (analytical) Water Content: ≤1.0% Particle Size: Controlled Application: R&D, method development
GMP Grade
Purity: ≥99.5% (pharmaceutical) Endotoxins: ≤2.5 EU/mg Microbial Limits: Compliant Application: Oncology formulations

Quality Standards

DRAVYOM's pharmaceutical grade Bendamustine 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
≥99.0% Pharmaceutical Purity
Advanced Analytical Testing
Comprehensive Impurity Control
Batch-to-Batch Consistency
Complete Documentation Package
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Pharmaceutical grade Bendamustine Hydrochloride exhibits exceptional chemical properties essential for oncological 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): 1.8
pKa: 2.2 ± 0.1
UV λmax: 223, 310 nm
Physical Properties
Melting Point: 150-160°C (decomp.)
Bulk Density: 0.4-0.6 g/mL
Crystalline Form: White to off-white crystalline powder
Hygroscopicity: Slightly hygroscopic
Pharmaceutical Performance
Bioavailability: 95% (intravenous)
Protein Binding: 94-96%
Half-life: 40 minutes
Elimination: Hepatic metabolism
Purity Specifications
Assay (HPLC): ≥99.0%
Related Substances: ≤1.0% total
Water Content: ≤0.5% (Karl Fischer)
Residue on Ignition: ≤0.1%
Stability Properties
Shelf Life: 2 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Stable 2-8°C
Container Compatibility: Amber glass, HDPE containers

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Bendamustine Hydrochloride superiority in oncological applications with exceptional cytotoxicity, stability, and reproducibility across diverse pharmaceutical formulations and clinical protocols.

Cytotoxic Activity

IC50: 5-50 μM depending on cell line

Potent alkylating agent activity
Solution Stability

Stable in aqueous solution for 24 hours

Pharmaceutical preparation stability
Bioavailability

95% intravenous bioavailability

Complete systemic exposure
Temperature Stability

Stable under refrigerated conditions

Consistent performance at 2-8°C
Batch Reproducibility

Variation: ±0.5% between batches

Exceptional lot-to-lot consistency
Shelf Stability

2 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Cytotoxic compound requiring specialized handling protocols. Use appropriate personal protective equipment including chemotherapy-grade gloves, protective clothing, and work in designated cytotoxic preparation areas. Avoid skin contact, inhalation, and ensure proper disposal according to cytotoxic waste guidelines.

Cytotoxic
Carcinogen
Specialized Handling

Storage & Handling

Store in original containers in a cool, dry place protected from light and moisture. Requires refrigerated storage and specialized cytotoxic handling procedures. Use appropriate containment and ensure controlled temperature environment.

Store at 2-8°C (refrigerated)
Protect from light
Cytotoxic handling required
Secure storage required

Chemical Mechanisms & Reaction Pathways

Bendamustine Hydrochloride exhibits bifunctional alkylating properties through nitrogen mustard and benzimidazole structure, enabling precise cytotoxic applications with predictable DNA crosslinking pathways and quantitative antineoplastic enhancement mechanisms.

DNA Crosslinking

Bifunctional alkylation leading to interstrand DNA crosslinks

Quantitative cell cycle arrest induction
Purine Analog Activity

Benzimidazole ring mimics purine bases in DNA synthesis

Essential for antimetabolite effects
Apoptosis Induction

Activation of p53-mediated apoptotic pathways

Enables targeted cancer cell death
Resistance Mechanisms

Unique activity against alkylator-resistant cell lines

Predictable therapeutic advantage

Regulatory Compliance & Documentation

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

USP Specifications

United States Pharmacopeia pharmaceutical standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical analysis

ICH Guidelines

International Conference on Harmonization pharmaceutical compliance

FDA Registration

United States Food and Drug Administration compliance

Method Validation

Supported analytical method validation documentation

SDS Documentation

Multi-language Safety Data Sheets (16 sections, GHS compliant)

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, stability testing assistance, and regulatory services to optimize pharmaceutical grade Bendamustine Hydrochloride performance in your specific therapeutic applications.

Formulation Development
  • Pharmaceutical formulation optimization support
  • Stability testing guidance
  • Bioavailability and bioequivalence validation
  • Custom pharmaceutical procedures
Analytical Services
  • Certificate of Analysis verification
  • Custom purity analysis
  • Impurity profiling and identification
  • Method validation support
Technical Support
  • Pharmaceutical troubleshooting consultation
  • Storage and handling guidance
  • Safety training and protocols
  • Manufacturing best practices
Supply Solutions
  • Consistent batch scheduling
  • Emergency supply arrangements
  • Custom packaging options
  • Global distribution network

Environmental Impact & Sustainability

Our pharmaceutical grade Bendamustine Hydrochloride production emphasizes environmental responsibility through sustainable manufacturing practices, waste minimization, and comprehensive environmental impact management for pharmaceutical operations.

Waste Minimization

Optimized production with minimal waste generation

Water Treatment

Advanced wastewater treatment and recycling systems

Clean Production

Energy-efficient synthesis with emission controls

Safe Disposal

Comprehensive guidance for pharmaceutical waste management

ISO 14001

Environmental management system certified production

Container Recycling

Pharmaceutical container return and recycling programs

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art pharmaceutical manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent pharmaceutical grade Bendamustine Hydrochloride quality and performance across all production batches.

Production Process

Advanced synthesis and purification in controlled cGMP environment

Multi-stage purification for pharmaceutical grade quality
Quality Testing

Comprehensive analytical testing protocol including purity, impurities, and stability

HPLC verification and spectroscopic analysis
Quality Systems

ISO 9001:2015 quality management with pharmaceutical manufacturing accreditation

Continuous improvement and process validation
Packaging Control

Pharmaceutical containers with controlled atmosphere packaging

Stability protection and contamination prevention

Market Applications & Performance Data

Comprehensive pharmaceutical development data demonstrating pharmaceutical grade Bendamustine Hydrochloride effectiveness across diverse therapeutic applications with quantified performance metrics and clinical study validations.

Pharmaceutical Manufacturing
Purity: >99.5% pharmaceutical grade Bioavailability: Consistent cytotoxic levels Stability: 36+ months under controlled conditions
Research Institutions
Clinical Studies: 400+ published research applications Reproducibility: >98% batch-to-batch consistency Innovation: Custom grade development
Generic Manufacturing
Regulatory Success: 100% FDA approval support Cost Efficiency: 25% reduction in manufacturing costs Quality Assurance: Zero batch failures

DRAVYOM Competitive Advantages

Superior Purity

Consistently exceeds pharmaceutical specifications with ultra-low impurities and exceptional therapeutic performance

Reliable Supply

Guaranteed availability with strategic inventory management and pharmaceutical-grade production scheduling

Pharmaceutical Expertise

Dedicated pharmaceutical development team provides formulation and regulatory support

Quality Assurance

Traceable certificates with comprehensive analytical data and regulatory compliance support

Global Standards

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

Partnership Approach

Collaborative relationships with pharmaceutical manufacturers and custom development services