Carmustine API
Pharmaceutical Oncology
Oncology API

Carmustine

High-purity pharmaceutical grade Carmustine API manufactured to meet stringent USP/EP specifications for cancer chemotherapy 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: C5H9Cl2N3O2
CAS Number: 154-93-8
Molecular Weight: 214.05 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 Chemotherapy Drug Manufacturing
Oncology Formulations
Injectable Pharmaceutical Products
API Synthesis & Development
Nitrosourea 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 Carmustine 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 Carmustine 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 Carmustine 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): Sparingly soluble
LogP (octanol/water): 1.5
pKa: Not applicable
UV λmax: 232 nm
Physical Properties
Melting Point: 30-32°C
Bulk Density: 0.3-0.5 g/mL
Crystalline Form: Yellow crystalline powder
Hygroscopicity: Non-hygroscopic
Pharmaceutical Performance
Bioavailability: 100% (intravenous)
Protein Binding: 80%
Half-life: 15-30 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: Store at -20°C
Container Compatibility: Amber glass vials

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Carmustine superiority in oncological applications with exceptional DNA alkylation, antitumor efficacy, and reproducibility across diverse pharmaceutical formulations and cancer therapeutic protocols.

DNA Alkylation

Nitrosourea-mediated DNA cross-linking

Potent antitumor activity
Solution Stability

Stable in reconstituted form for 8 hours

Limited administration window
Bioavailability

100% intravenous bioavailability

Complete systemic exposure
Temperature Stability

Stable under frozen conditions

Consistent performance at -20°C
Batch Reproducibility

Variation: ±0.3% between batches

Exceptional lot-to-lot consistency
Shelf Stability

2 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Highly 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.

Highly Cytotoxic
Carcinogen
Specialized Handling

Storage & Handling

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

Store at -20°C (frozen)
Protect from light
Cytotoxic handling required
Secure storage required

Chemical Mechanisms & Reaction Pathways

Carmustine exhibits antineoplastic properties through DNA alkylation and crosslinking mechanisms, enabling predictable therapeutic response with well-characterized pharmacokinetic and pharmacodynamic profiles.

Mechanism of Action

DNA alkylation and crosslinking causing cell death

Targeted cancer cell DNA damage
Metabolic Pathway

Rapid hydrolysis to active alkylating species

Non-enzymatic activation mechanism
Pharmacokinetics

Intravenous administration with 20-minute half-life

Rapid distribution and clearance
Elimination

Hepatic metabolism with pulmonary excretion

Unique elimination pathway

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

Pharmaceutical Formulations
Bioavailability: Intravenous administration Half-life: 20 minutes rapid clearance Stability: 2+ years frozen storage
Clinical Applications
Efficacy: 30-40% brain tumor response Safety: Delayed pulmonary toxicity Dosage: 150-200 mg/m² standard dose
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