Kegunaan Ampicillin Trihydrate

Ampicillin Trihydrate is a semi-synthetic penicillin derivative with enhanced stability and broad-spectrum antibacterial activity. This β-lactam antibiotic is particularly effective against both Gram-positive and Gram-negative bacteria, making it a versatile choice for various pharmaceutical applications.

Physical & Chemical Properties:

• PH (1% suspension): 3.5 - 6.0
• Melting Point: Decomposes at approximately 203°C
• Specific Rotation: +280° to +305° (1% in water)
• Heavy Metals: ≤ 20 ppm
• Related Substances: Total impurities ≤ 2.0%

Microbiological Properties:

• Potency: ≥ 900 mcg/mg (calculated on anhydrous basis)
• Sterility: Meets EP/USP sterility requirements
• Bacterial Endotoxins: < 0.15 EU/mg

Packaging Specifications:

• Primary packaging: Double polyethylene bags
• Secondary packaging: Sealed fiber drums
• Standard quantity: 25 kg per drum
• Custom packaging available

Our Ampicillin Trihydrate meets stringent international quality standards and holds the following certifications:

Quality Certifications:

✅ GMP Certified Manufacturing (Good Manufacturing Practice)

✅ ISO 9001:2015 Quality Management System

✅ ISO 14001:2015 Environmental Management System

✅ USP/EP/BP Compliance (United States/European/British Pharmacopoeia)

✅ CE Certification for European markets

Regulatory Approvals:

Legal business licenses for antibiotic manufacturing

Export certifications for international markets

Certificate of Analysis with each batch

Material Safety Data Sheet (MSDS) available

Quality Assurance:

Batch-to-batch consistency guaranteed

Comprehensive stability studies

Microbial contamination control

Heavy metals testing compliance

Primary Functions:

Broad-spectrum antibacterial activity against Gram-positive and Gram-negative bacteria

Bactericidal action through inhibition of cell wall synthesis

Effective against β-lactamase non-producing bacteria

Good tissue penetration and distribution

Human Medicine:

Treatment of respiratory tract infections (pneumonia, bronchitis)

Management of urinary tract infections

Treatment of gastrointestinal infections

Control of skin and soft tissue infections

Management of meningitis and septicemia

Veterinary Medicine:

Treatment of bacterial infections in livestock

Control of poultry diseases

Management of companion animal infections

Aquaculture applications

Pharmaceutical Formulations:

Oral capsule and tablet formulations

Powder for oral suspension

Injectable formulations (after processing)

Veterinary medicinal products

Acid stability allowing oral administration

Enhanced water solubility compared to other forms

Good bioavailability when administered orally

Compatibility with various pharmaceutical excipients

Research and development studies

Microbiology laboratory applications

Pharmaceutical manufacturing

Veterinary product formulation

SHANDONG HIGH CHEM-PHARM CO., LTD ensures that our Ampicillin Trihydrate meets the highest quality standards while maintaining competitive pricing. Our product is backed by comprehensive technical support and reliable supply chain management, making us the preferred choice for pharmaceutical manufacturers worldwide.