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Amoxicillin Trihydrate

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Amoxicillin Trihydrate pharmaceutical raw material
Quick Facts
CAS Number61336-70-7
Molecular FormulaC16H19N3O5S · 3H2O
Molecular Weight419.45
PharmacopoeiaBP/EP/USP/CEP/IN HOUSE
Packaging25 KG/DRUM
USP Standard EP/BP Standard

Product Story

Amoxicillin was synthesized in 1972 at Beecham Research Laboratories in the UK, building on the earlier success of ampicillin (1961). The team, led by researchers who had previously developed the first semi-synthetic penicillins, created amoxicillin by adding a hydroxyl group to ampicillin's phenyl side chain. This single structural change — which chemically distinguishes amoxicillin from its predecessor — dramatically improved oral absorption: from ~35% bioavailability for ampicillin to approximately 80-95% for amoxicillin. The compound was launched as Amoxil in 1974 and has since become one of the most prescribed antibiotics in global medical history.

Amoxicillin exerts its bactericidal effect by irreversibly binding to penicillin-binding proteins (PBPs) on the bacterial cell wall, specifically inhibiting transpeptidase enzymes that cross-link peptidoglycan strands during cell division. This leads to cell lysis and death. Its aminopenicillin structure extends the spectrum beyond penicillin G to include many Gram-negative organisms — notably E. coli, H. influenzae, and H. pylori — while retaining strong activity against streptococci and enterococci. The trihydrate form ensures crystalline stability, with three water molecules incorporated into the crystal lattice to prevent the hygroscopic degradation that plagues the anhydrous form.

Amoxicillin's clinical advantage over ampicillin is threefold: superior oral bioavailability enabling twice-daily (BID) dosing versus ampicillin's three-to-four-times daily regimen; higher and more sustained serum concentrations; and significantly fewer gastrointestinal side effects. This pharmacokinetic profile, combined with the addition of beta-lactamase inhibitors (clavulanic acid as co-amoxiclav), has made amoxicillin the backbone of first-line therapy for respiratory tract infections, urinary tract infections, and H. pylori eradication worldwide. The WHO lists amoxicillin on its Model List of Essential Medicines, and the co-amoxiclav combination is listed as an Access-group antibiotic.

As of mid-2026, global amoxicillin trihydrate API demand exceeds 25,000 metric tons annually, driven by high-volume manufacturing in India and China. China dominates the upstream intermediate supply chain (6-APA, produced from penicillin G via enzymatic cleavage) and accounts for the largest share of amoxicillin API production. Price volatility is closely linked to 6-APA feedstock costs and production capacity utilization in Shijiazhuang and Inner Mongolia. KingWish supplies GMP-certified amoxicillin trihydrate meeting BP/EP/USP/CEP/IN HOUSE standards, supporting pharmaceutical manufacturers worldwide with competitive lead times and full regulatory documentation.

Quality Specifications

Assay (HPLC, anhydrous)95.0% – 102.0%, per BP/EP/USP monograph
Water Content (Karl Fischer)11.5% – 14.5% (trihydrate specification)
Related SubstancesIndividual impurity ≤ 1.0%, total impurities ≤ 3.0% (EP)
pH (0.2% aqueous)3.5 – 5.5
Residual SolventsCompliant with ICH Q3C; acetone ≤ 5,000 ppm
GMP StatusManufactured under ICH Q7 GMP conditions

Therapeutic Applications

  • Respiratory tract infections: First-line oral therapy for community-acquired pneumonia, acute bronchitis, and sinusitis caused by S. pneumoniae and H. influenzae.
  • Urinary tract infections: First-line treatment for uncomplicated UTIs caused by susceptible Enterobacteriaceae. BID dosing improves compliance over ampicillin.
  • H. pylori eradication: Component of standard triple therapy (amoxicillin + clarithromycin + proton pump inhibitor) for 7-14 days. Amoxicillin resistance in H. pylori remains low compared to clarithromycin.
  • Otitis media: Pediatric oral suspension for acute otitis media. High-dose regimen (80-90 mg/kg/day) recommended in regions with high penicillin-nonsusceptible pneumococcal rates.
  • Dental infections: Prophylaxis and treatment of odontogenic infections; also used for infective endocarditis prophylaxis in at-risk patients per AHA guidelines.
Standards: BP/EP/USP/CEP/IN HOUSE  |  CAS: 61336-70-7  |  Quality data verified against pharmacopoeia monograph COA and MSDS available  |  DrugBank  |  July 2026

Sourcing Amoxicillin Trihydrate: Key Checks

Documentation

Request CoA with HPLC assay (95.0-102.0% anhydrous), water content (11.5-14.5%), related substances profile, and residual solvent statement (ICH Q3C). For EU markets, CEP certificate is the gold standard of quality documentation.

Red Flags

Undisclosed 6-APA source (penicillin impurity carryover), water content outside 11.5-14.5% indicating wrong hydrate form, prices unusually below 6-APA feedstock cost, and reluctance to share batch-specific related substances HPLC chromatograms.

Packaging & Logistics

Standard: 25 KG/DRUM with double LDPE liner. Store at 15-25°C, protected from moisture. Amoxicillin is temperature-sensitive; verify cold-chain or temperature-controlled container availability for long-distance shipments during summer months.

Market Context

Global amoxicillin API market exceeds 25,000 MT/year. China controls the 6-APA intermediate supply chain. Prices correlate with 6-APA feedstock costs and penicillin G capacity utilization. CEP-certified amoxicillin commands a premium over generic commercial grade. Market report

Frequently Asked Questions

Amoxicillin trihydrate is a broad-spectrum beta-lactam antibiotic used to treat respiratory tract infections (pneumonia, bronchitis, sinusitis), urinary tract infections, otitis media, H. pylori eradication (in triple therapy with clarithromycin and a proton pump inhibitor), and dental infections. It is the most widely prescribed antibiotic in the aminopenicillin class globally, formulated as tablets, capsules, oral suspensions, and injectables.
Three key differences: (1) Amoxicillin has significantly better oral bioavailability (~80-95%) compared to ampicillin (~30-55%), meaning more drug reaches the bloodstream after oral dosing. (2) Amoxicillin achieves higher and more sustained serum concentrations, enabling twice-daily (BID) dosing vs. the three-to-four times daily dosing typically required for ampicillin. (3) Amoxicillin produces fewer GI side effects and has largely replaced oral ampicillin in clinical practice worldwide, with roughly three times the global production volume.
Amoxicillin trihydrate should be stored at controlled room temperature (15-25°C) in tightly sealed containers protected from moisture and light. The trihydrate form is relatively stable, but excessive heat (>30°C) or humidity can accelerate degradation and reduce potency. Bulk API in 25 KG drums should be kept in dry, well-ventilated storage and used within the manufacturer-recommended retest period, typically 2-3 years from the date of manufacture when stored under proper conditions.
For regulated markets, confirm the supplier holds a valid GMP certificate (ICH Q7) and, where applicable, a Certificate of Suitability (CEP) from the EDQM for the European market. Request a batch-specific Certificate of Analysis (CoA) with HPLC assay results (typically 95.0-102.0% on anhydrous basis per BP/EP/USP), related substances profile, water content (11.5-14.5%), and residual solvent statement per ICH Q3C. For markets requiring stability data, verify that accelerated and long-term stability studies per ICH Q1A are available.

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