Basic Product Information
Amoxicillin Trihydrate is a broad-spectrum semi-synthetic penicillin antibiotic used in various pharmaceutical formulations. This white crystalline powder offers excellent stability and solubility characteristics, making it suitable for multiple dosage forms including oral suspensions, capsules, and tablets.
|
Parameter |
Specification |
|
Product Name |
Amoxicillin Trihydrate |
|
CAS Number |
61336-70-7 |
|
Molecular Formula |
C₁₆H₁₉N₃O₅S·3H₂O |
|
Appearance |
White crystalline powder |
|
Purity |
98.5-101.0% (on anhydrous basis) |
|
Water Content |
12.0-15.0% |
|
Solubility |
Soluble in water |
Compliance and Certifications
Our Amoxicillin Trihydrate manufacturing facility operates under strict Good Manufacturing Practice (GMP) guidelines certified by international regulatory bodies. The product complies with United States Pharmacopeia (USP), European Pharmacopoeia (EP), and British Pharmacopoeia (BP) standards. We maintain ISO 9001:2015 quality management system certification and ISO 14001:2015 environmental management system certification. All batches undergo rigorous quality control testing and are accompanied by Certificate of Analysis, Material Safety Data Sheets, and relevant regulatory documentation. Our quality assurance system includes comprehensive stability studies and regular environmental monitoring to ensure consistent product quality.
Functions and Applications
Amoxicillin Trihydrate demonstrates bactericidal activity against both Gram-positive and Gram-negative microorganisms through inhibition of cell wall synthesis. The product is effective against streptococci, pneumococci, enterococci, Haemophilus influenzae, Escherichia coli, and other susceptible bacteria. Primary therapeutic applications include treatment of respiratory tract infections such as bronchitis and pneumonia, ear nose and throat infections including otitis media and sinusitis, genitourinary tract infections including cystitis and urethritis, skin and soft tissue infections, and dental infections. The product is also used in combination with other medications for Helicobacter pylori eradication therapy.
Packaging and Storage
The product is packaged in double polyethylene bags within sealed fiber drums containing desiccant to maintain stability. Standard packaging includes 25 kg per drum with custom packaging options available from 1 kg to 10 kg quantities. All packaging materials comply with international standards for pharmaceutical products and feature moisture-proof and light-resistant properties. Storage requires maintaining temperature between 2-8 degrees Celsius in a dry well-ventilated area protected from light. The product must be kept in original sealed packaging until use and should be handled under low humidity conditions to prevent moisture absorption. Shelf life is 36 months when stored under recommended conditions with regular stability monitoring.
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