| Product name | Cefoperazone+Sulbactam 1:1 | |
| Shelf life | 2 years | |
| ITEM | SPECIFICATION | RESULTS |
| Appearance | White or almost white crystalline powder | Almost white crystalline Powder |
| Acidity(PH) | 3.5~6.5 | 5.60 |
| Turbidity | No more than No.1 | Pass |
| Color of solution | No more than Y4 or YG4 | <Y2 |
| Clarity | Confirm | Pass |
| Water | No more than 4.0% | 1.7% |
| Impurity A | No more than 1.5% | 0.14% |
| Impurity C | No more than 0.5% | 0.09% |
| Single Impurity | No more than 1.5% | 0.15% |
| Total impurities | No more than 3.0% | 1.0% |
| Undissolved particles |
≥10μ m≤6000 ≥25μ m≤6000 |
20 0 |
| Bacterial Endotoxins | No more than 0.050 EU/mg | Pass |
| Sterility | Confirm | Pass |
| Assay | Cefoperazone not less than 435 ug/mg | 460 ug/mg |
| Sulbactam not less than 445 ug/mg | 457 ug/mg | |
| Conclusion:Conforms to Ch.P2015 | ||