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Fosfomycin tromethamine is a phosphonic acid bactericidal agent with in vitro activity against most urinary tract pathogens. It is particularly active against Escherichia coli, and Citrobacter, Enterobacter, Klebsiella, Serratia and Enterococcus spp. There appears to be little cross-resistance between fosfomycin and other antibacterial agents, possibly because it differs from other agents in its general chemical structure and site of action
| Items | Specifications | Results |
| Characteristics | White or almost white powder | Almost white powder |
| Identification | IR: Complies | Complies |
| Specific Rotation(anhydrous substance ) | -12.5°~-13.5° | -13.12° |
| Water | ≤0.5% | 0.15% |
| Acidity(pH ) | 3.5~5.5 | 4.88 |
| Heavy Metals | ≤0.0010% | <0.0010% |
| Phosphates | ≤0.0500% | <0.0500% |
| Related Substances | Impurity A: ≤0.3% | Not detected |
| Impurity B: ≤0.3% | 0.09% | |
| Impurity C: ≤0.1% | Not detected | |
| Impurity D: ≤0.1% | Not detected | |
| Unspecified impurity:≤0.1% | Not detected | |
| Total: ≤0.5% | 0.09% | |
| Residual Solvents | Methanol:≤0.3% | 0.10% |
| Methyl tert-butyl ether: ≤0.5% | 0.00% | |
| Assay | 98.0%~102.0% | 100.50% |
Fosfomycin tromethamine is a bactericidal phosphonic acid derivative which acts primarily by inhibiting bacterial cell wall (peptidoglycan) synthesis. It has antibacterial activity against many pathogenic and opportunistic Gram-positive and Gram-negative bacteria isolated from patients with lower urinary tract infections (UTI). According to conventional in vitro susceptibility tests, fosfomycin has good activity against Escherichia coli, Staphylococcus aureus, and Serratia, Klebsiella, Citrobacter, Enterococcus and Enterobacter spp. Minimum inhibitory concentrations active against 90% of isolates (MIC90 values) for some other important pathogens are relatively high, but are well within the urinary concentrations of fosfomycin achieved during treatment with the drug.
