| TESTING ITEMS | SPECIFICATIONS | RESULTS |
| Characteristics | White or almost white crystalline powder | Conforms |
| Identification | The infrared absorption spectrum of the sample spectrum exhibits maxima at the same wavelengths as that of a know standard of piperacillin monohydrate | Conforms |
| PH | 2.5~4.0 | 3.6 |
| Specific optical rotation | +160°~+178° | +172° |
| Related substances | Impurity A ≤1.0% | 0.25% |
| Impurity B ≤0.2% | 0.05% | |
| Impurity C ≤0.4% | 0.12% | |
| Impurity D ≤2.0% | 0.23% | |
| Other maximum single impurity ≤0.1% | 0.08% | |
| Total impurities ≤3.8% | 1.5% | |
| Water | 2.0%~4.0% | 3.6% |
| Ampicillin | ≤0.2% | 0.01% |
| Bacterial endotoxins | ≤0.05EU/mg | 0.002EU/mg |
| Assay | 96.0%~103.0% | 99.4% |
| Conclusion: The Product Conforms to USP/EP. |
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