Overview
Amoxicillin trihydrate (CAS 61336-70-7 ) is a broad-spectrum beta-lactam antibiotic active pharmaceutical ingredient used in the manufacture of finished oral and injectable dosage forms. It serves as the primary antibacterial agent in a wide range of prescription drug products.
This essential compound targets bacterial infections across human and veterinary medicine. In human pharmaceutical manufacturing, it is compounded into capsules, tablets, and oral suspensions, which are among the highest-volume antibiotic dosage forms produced globally.
Veterinary drug manufacturers incorporate it into formulations for livestock and companion animals. In these applications, it effectively addresses respiratory, urinary, and soft tissue bacterial infections to ensure animal health and safety.
It is also used in the production of combination products, most notably paired with clavulanic acid. This combination is designed to overcome bacterial resistance in augmented antibiotic formulations used in clinical settings.
Amoxicillin trihydrate is supplied as a white to off-white crystalline powder. Standard grades include USP , BP , and Ph. Eur. , with compendial specifications governing particle size, potency, and residual solvent limits.
These quality standards are relevant to finished dosage form performance and regulatory compliance. Bulk supply is available in fiber drums with controlled humidity packaging to maintain stability across international shipments.
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Physical Properties
| Melting Point | >200°C (dec.) |
| Color | White to Off-White |
| Form | neat |
| Water Solubility | Soluble in water at 3.4mg/ml. |
| Refractive Index | 302 ° (C=0.1, H2O) |
Safety & Handling
Danger GHS07 GHS08 GHS09 Hazard Statements H317 H317 H334 H334 H400 H400 H410 H410 Precautionary Statements P233 P233 P260 P260 P261 P261 P271 P271 P272 P272 P273 P273 P280 P280 P284 P284 P321 P321 P391 P391 P403 P403 P501 P501 P302+P352 P302+P352 P304+P340 P304+P340 P333+P317 P333+P317 P342+P316 P342+P316 P362+P364 P362+P364
Trade & Regulatory
| HS Code | 29411099 |
| Storage Class | 11 - Combustible Solids |
| WGK (Germany) | 2 |
Other Names
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Chemical Properties
- CAS Number
- 61336-70-7
- EC Number
- 612-127-4
- Mol. Weight
- 419.5
- HS Code
- 29411099
- Category
- Pharmaceutical Intermediates