Gemcitabine Hydrochloride API
Pharmaceutical Oncology
Oncology API

Gemcitabine Hydrochloride

High-purity pharmaceutical grade Gemcitabine Hydrochloride 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: C9H11F2N3O4·HCl
CAS Number: 122111-03-9
Molecular Weight: 299.66 g/mol
Purity (HPLC): ≥99.0% (pharmaceutical grade)
Physical State: White to off-white crystalline powder
Water Content (Karl Fischer): ≤1.0%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% total impurities
Storage Conditions: Store in cool, dry place (15-25°C)
Packaging Options: 100g, 500g pharmaceutical containers

Applications

Cancer Chemotherapy Manufacturing
Pancreatic Cancer Treatment Formulations
Nucleoside Analog Products
API Synthesis & Development
Oncology Research Applications
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 Gemcitabine Hydrochloride grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse cancer chemotherapy and nucleoside analog drug manufacturing applications.

USP Grade (Pharmaceutical)
Purity: ≥99.0% (HPLC) Water Content: ≤1.0% 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: ≤1.5% 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 Gemcitabine 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
Ultra-Low Impurities
Batch-to-Batch Consistency
Traceable Certificate of Analysis
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Pharmaceutical grade Gemcitabine Hydrochloride exhibits precise chemical properties essential for oncological formulations. Its ultra-pure composition and exact molecular structure ensure reliable therapeutic performance in demanding pharmaceutical applications.

Pharmaceutical Properties
Molecular Weight: 299.66 g/mol
Melting Point: 290-295°C
Solubility (Water): >100 mg/mL at 25°C
pH (5% solution): 2.5-3.5
Physical Properties
Appearance: White to off-white powder
Crystalline Form: Crystalline solid
Bulk Density: 0.45-0.55 g/mL
Hygroscopicity: Slightly hygroscopic
Pharmaceutical Performance
Bioavailability: 100% IV administration
Half-life: 42-94 minutes
Protein Binding: Negligible
Metabolism: Deaminase pathway
Purity Specifications
Assay: ≥99.0% (HPLC)
Related Substances: ≤0.1% total
Residual Solvents: ICH Q3C compliant
Heavy Metals: ≤10 ppm
Stability Properties
Shelf Life: 3 years (unopened)
Storage Temperature: 2-8°C
Light Sensitivity: Protect from light
Moisture Sensitivity: Store in dry conditions

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Gemcitabine Hydrochloride superiority in oncological applications with exceptional stability, bioavailability, and reproducibility across diverse pharmaceutical formulations.

Formulation Performance

Compatibility: Excellent with standard excipients

Consistent injection preparation
Therapeutic Efficacy

Bioequivalence: 95-105% reference standard

Proven therapeutic equivalence
Dissolution Profile

Release: Rapid IV dissolution

Optimal pharmaceutical performance
Thermal Stability

Stability: <0.1% degradation/year at 2-8°C

Excellent long-term stability
Batch Consistency

Variation: ±0.3% between production batches

Exceptional pharmaceutical uniformity
Shelf Stability

3 years under controlled storage conditions

Extended pharmaceutical grade integrity

Safety Information

Pharmaceutical grade oncological compound requiring proper handling procedures. Use appropriate personal protective equipment including gloves, safety goggles, and protective clothing. Ensure adequate ventilation and follow established pharmaceutical handling protocols.

Handle with Care
Eye Protection Required
Avoid Inhalation

Storage & Handling

Store in original pharmaceutical containers in a cool, dry, well-ventilated area away from incompatible materials. Keep containers tightly closed and protect from light and moisture. Follow cGMP storage requirements for pharmaceutical materials.

Controlled temperature (2-8°C)
Protect from moisture
Original pharmaceutical packaging
Protect from direct light

Chemical Mechanisms & Reaction Pathways

Gemcitabine Hydrochloride exhibits selective antimetabolite activity through specific incorporation into DNA synthesis pathways, enabling precise oncological applications with predictable pharmacokinetic pathways and quantitative cellular interactions.

DNA Synthesis Inhibition

Active metabolite incorporation into DNA chain termination

Therapeutic mechanism for cancer treatment
Ribonucleotide Reductase Inhibition

Reduction of cellular dNTP pools essential for DNA synthesis

Essential for antineoplastic activity
Cell Cycle Arrest

S-phase specific cell cycle blockade and apoptosis induction

Enables selective therapeutic applications
Metabolic Activation

Selective phosphorylation to active diphosphate and triphosphate forms

Controlled therapeutic environment for treatment

Regulatory Compliance & Documentation

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

USP Grade Specifications

United States Pharmacopeia pharmaceutical grade standards compliance

EP Monograph Standard

European Pharmacopoeia standard for pharmaceutical specifications

IP Grade Available

Indian Pharmacopoeia specifications for pharmaceutical analysis

ICH Guidelines

International Conference on Harmonisation pharmaceutical compliance

Method Validation

Supported pharmaceutical 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, and regulatory services to optimize Gemcitabine Hydrochloride performance in your specific pharmaceutical applications.

Formulation Development
  • Pharmaceutical formulation optimization support
  • Stability testing guidance
  • Bioavailability and bioequivalence studies
  • 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
  • cGMP best practices
Supply Solutions
  • Consistent batch scheduling
  • Emergency supply arrangements
  • Custom packaging options
  • Global distribution network

Environmental Impact & Sustainability

Our Gemcitabine 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 purification technology and continuous monitoring systems to ensure consistent Gemcitabine 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 cGMP compliance

Continuous improvement and method validation
Packaging Control

Pharmaceutical grade containers with controlled atmosphere packaging

Light protection and contamination prevention

Market Applications & Performance Data

Comprehensive pharmaceutical data demonstrating Gemcitabine Hydrochloride effectiveness across diverse oncological applications with quantified performance metrics and clinical validation.

Pharmaceutical Manufacturing
Purity: >99.5% pharmaceutical grade Bioavailability: >90% in formulations Stability: 3 years shelf life
Research Institutions
Publications: 1000+ cited studies Clinical Trials: 50+ ongoing studies Innovation: Custom formulation development
Contract Manufacturing
Reliability: 99.9% batch consistency Compliance: 100% regulatory approval Efficiency: 25% faster processing

DRAVYOM Competitive Advantages

Superior Purity

Consistently exceeds pharmacopeia specifications with ultra-low impurities and exceptional pharmaceutical 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 stability studies

Global Standards

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

Partnership Approach

Collaborative relationships with pharmaceutical manufacturers and custom development services