Doxycycline Hyclate Powder

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Doxycycline Hyclate Powder
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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.
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Doxycycline Hyclate
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Description

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.

 

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