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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 |