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Amoxicillin Trihydrate
Pharmaceutical Chemistry

Amoxicillin Trihydrate

Formula: C16H19N3O5S·3H2O GOST/CAS: CAS 61336-70-7

Amoxicillin Trihydrate is a semi-synthetic, broad-spectrum antibiotic belonging to the penicillin group. It serves as a primary Active Pharmaceutical Ingredient (API) for the synthesis of finished dosage forms (FDF) and veterinary medicines. The product is a white or almost white crystalline powder. Due to its high bioavailability and stability, Amoxicillin easily integrates into manufacturing processes for tablets, capsules, suspensions, and water-soluble powders, delivering a potent therapeutic effect and bactericidal action against a wide range of Gram-positive and Gram-negative microorganisms.

Applications

Pharmaceutical Industry: Acts as a core substrate for the synthesis of antibacterial drugs in human medicine (capsules, tablets, dry suspensions).
Veterinary Medicine: Extensively used in manufacturing long-acting injectable suspensions, oral powders, and soluble solutions for treating bacterial infections in livestock and poultry.
Premix Production: Incorporated into medicated feed additives and premixes for livestock and swine farming.
Specialized Finished Forms: Used in manufacturing combination drugs with beta-lactamase inhibitors (e.g., Potassium Clavulanate) to overcome bacterial resistance.

Key Advantages

Broad-Spectrum Activity: Highly effective against most clinically significant bacterial strains (including Streptococcus spp., Staphylococcus spp., E. coli, Salmonella spp., etc.).
Excellent Processability: Consistent particle size distribution and optimal powder flowability ensure high dosing accuracy during encapsulation and tableting.
High Bioavailability: Rapidly absorbed from the gastrointestinal tract and highly stable in gastric acid, guaranteeing swift peak concentrations in target tissues.
Safety & Quality Control: Fully complies with EP / USP / BP standards (European, US, and British Pharmacopoeias), featuring low impurity profiles and complete absence of toxic solvents.

Storage & Transportation

  • Store in dry, cool, and well-ventilated warehouses in the original, tightly sealed factory packaging.
  • Avoid exposure to direct sunlight and moisture (highly hygroscopic product), and prevent exposure to elevated temperatures (above 25°C).
  • Transportation is permissible via all types of covered transport in compliance with pharmaceutical raw material shipping regulations. Classified as non-hazardous cargo. Shelf life — 3 years.

Technical Specifications

Appearance White or almost white crystalline powder
Molecular Weight ~ 419.45 g/mol
Specific Optical Rotation +290° to +315°
Moisture Content (Water) 11.5% – 14.5%
pH (0.2% aqueous solution) 3.5 – 5.5
Assay (on anhydrous basis) ≥ 98.0%

Supply info

  • Multi-layer paper bags or double polyethylene liners packed inside 25 kg fiber drums.
  • FIBC (Big-Bags) weighing 500 – 1000 kg (upon agreement with the customer, primarily utilized for veterinary feed-grade batches).

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