Basic Product Information
Doxycycline Hyclate Powder is a high-purity, semi-synthetic tetracycline derivative specifically designed for pharmaceutical manufacturing. This versatile antibiotic compound offers broad-spectrum activity against various pathogens while maintaining excellent stability and solubility characteristics.
|
Parameter |
Specification |
|
Product Name |
Doxycycline Hyclate Powder |
|
CAS Number |
24390-14-5 |
|
Molecular Formula |
C₂₂H₂₄N₂O₈·HCl·½C₂H₅OH·½H₂O |
|
Appearance |
Yellow to yellow crystalline powder |
|
Purity (HPLC) |
≥ 98.0% |
|
Water Content |
≤ 2.0% |
|
Solubility |
Freely soluble in water |
|
Particle Size |
80-120 mesh |
Functions & Applications
Doxycycline Hyclate Powder demonstrates potent bacteriostatic activity through inhibition of protein synthesis by binding to the 30S ribosomal subunit. Its broad-spectrum efficacy covers Gram-positive and Gram-negative bacteria, mycoplasma, chlamydia, and rickettsia.
Pharmaceutical Applications:
Oral solid dosage formulations (tablets, capsules)
Powder for reconstitution into oral suspensions
Veterinary medicinal products
Topical formulations and creams
Emergency antibiotic stockpiles
Therapeutic Uses:
Respiratory tract infections treatment
Skin and soft tissue infections management
Sexually transmitted diseases control
Malaria prophylaxis and treatment
Lyme disease and tick-borne illnesses
Acne vulgaris treatment formulations
Specialized Applications:
Cell culture contamination control
Research and development applications
Diagnostic reagent manufacturing
Antibiotic susceptibility testing
Industrial Advantages:
Excellent batch-to-batch consistency
Superior compressibility for tablet formation
Optimal flow characteristics for encapsulation
Enhanced stability in various formulations
Compatibility with common pharmaceutical excipients
Packaging & Storage
Packaging Specifications:
- Primary containment: Double polyethylene bags with moisture barrier
- Secondary packaging: Sealed fiber drums with desiccant
- Standard quantity: 25 kg per drum
- Custom packaging: 1 kg, 5 kg, and 10 kg options
- Quality assurance: Batch-specific labeling with QR codes
Storage Requirements:
- Temperature: 2-8°C for long-term storage
- Humidity: Maintain below 45% RH
- Light protection: Amber containers or light-resistant packaging
- Ventilation: Dry, well-ventilated storage area
- Shelf life: 36 months in unopened original packaging
Handling Protocols:
Use appropriate personal protective equipment
Avoid dust generation during handling
Implement closed-system transfer where possible
Store separately from strong oxidizing agents
Maintain strict inventory rotation system
Stability Management:
Regular stability testing under ICH guidelines
Temperature and humidity monitoring
Light exposure protection measures
Container integrity verification
Production & Processing
Manufacturing Excellence:
Our production process employs state-of-the-art technology to ensure superior quality:
- Synthesis Process: Multi-step chemical synthesis under controlled conditions
- Purification Technology: Advanced crystallization and filtration systems
- Quality Control: Real-time monitoring of critical process parameters
- Particle Engineering: Precision milling for optimal particle size distribution
Quality Assurance Systems:
Raw material qualification and testing
In-process quality checks at 20 critical control points
Final product comprehensive testing
Stability studies following ICH guidelines
Environmental monitoring throughout production
Facility Capabilities:
GMP-certified manufacturing facilities
Climate-controlled production areas
Automated material handling systems
Advanced dust containment technology
Dedicated quality control laboratories
Technical Specifications:
- Production capacity: 100+ metric tons annually
- Batch size flexibility: 50kg to 1000kg
- Customization options: Particle size, purity grades
- Documentation: Complete DMF and regulatory support
Innovation & Development:
Continuous process optimization
New formulation development support
Analytical method development
Custom synthesis capabilities
SHANDONG HIGH CHEM-PHARM CO., LTD maintains the highest quality standards in Doxycycline Hyclate Powder production, ensuring reliable supply for pharmaceutical manufacturers worldwide. Our commitment to excellence extends from raw material selection to final product delivery.
Hot Tags: doxycycline hyclate powder, China doxycycline hyclate powder manufacturers, factory