Amoxicillin Trihydrate

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Product Name :	Amoxicillin Trihydrate
Specs :	USP/BP/EP
Cas No.：	61336-70-7
Product Serie：	Penicillins & Cephalosporins Series
Product  Details ：	Molecular Formula: C16H19N3O5S.3(H2O)    Molecular Weight: 419.45

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Overview

Derived from 6-aminopenicillanic acid, it exhibits broad-spectrum bactericidal activity by inhibiting bacterial cell wall synthesis. This white crystalline powder is freely soluble in water, stable in acidic environments (pH 3-5), and widely used in oral formulations due to its acid resistance and high bioavailability.

Features

Antibacterial Spectrum:

Gram-Positive: Effective against Streptococcus pneumoniae, Staphylococcus aureus (non-MRSA), and Enterococcus faecalis.

Gram-Negative: Active against Haemophilus influenzae, Escherichia coli, and Proteus mirabilis, though less potent against Pseudomonas aeruginosa.

Mechanism: Binds penicillin-binding proteins (PBPs), disrupting peptidoglycan cross-linking, leading to cell lysis, particularly in actively dividing bacteria.

Pharmacokinetic Superiority:

Oral Bioavailability: 90% when taken orally (vs. 60% for ampicillin), unaffected by food, with peak plasma concentrations of 7-10 μg/mL (500 mg dose), ideal for pediatric and adult use.

Tissue Penetration: Distributes well into body fluids (CSF, bile, breast milk), achieving therapeutic levels in sinus, middle ear, and urinary tract infections.

Excretion: 60% unchanged in urine via renal tubular secretion, the half-life of 1-1.5 hours, necessitating 8-12-hour dosing (q8h for severe infections).

Formulation Advantages:

Stability: Trihydrate form offers better moisture resistance than anhydrous amoxicillin, ensuring shelf life >24 months at <25°C in sealed containers.

Combination Utility: Paired with clavulanic acid (as co-amoxiclav) to inhibit β-lactamase enzymes, restoring activity against resistant strains (e.g., β-lactamase-producing H. influenzae).

Applications

Infectious Disease Therapy:

Respiratory Infections: First-line for otitis media (children), sinusitis, and community-acquired pneumonia (CAP), often as monotherapy or in combination with macrolides for atypical coverage.

Urinary Tract Infections (UTIs): Effective against E. coli and Proteus species, particularly in uncomplicated cystitis (3-day course in non-pregnant adults).

Skin and Soft Tissue Infections: Treats cellulitis, abscesses (with drainage), and animal bites, leveraging its rapid bactericidal action.

Prophylactic Use:

Endocarditis Prophylaxis: Recommended for high-risk patients (valvular heart disease) before dental procedures (2g oral dose 1 hour prior).

Surgical Prophylaxis: Used in gastrointestinal/genitourinary surgeries to prevent S. aureus and enteric bacterial infections.

Pediatric Applications:

Suspensions and Chewables: Palatable formulations (strawberry/banana flavor) with accurate dosing (10-20 mg/kg/dose), critical for pediatric compliance and safety.

Quality Assurance

Our Amoxicillin Trihydrate meets BP, USP, and EP monographs, with a specific optical rotation [α]²⁰ₙ +290° to +310° (water) and bacterial endotoxin levels <0.5 EU/mg for parenteral use (though primarily oral). Impurity profiles are controlled to ≤0.2% for penicillenic acid and ≤0.1% for other related compounds, ensuring safety and efficacy in all formulations.