Name of product | Cefuroxime Axetil | |
Shelf life | 2 years | |
TESTS | SPECIFICATIONS | RESULTS |
CHARACTERS | A white to almost white powder | An almost white powde |
Identification | IR, infrared absorption spectrogram of the test solution is similar to that of the reference solution | Conforms |
Crystallinity | Don’t show birefringence or exhibit extinction positions | Conforms |
Water | <1.5% | 0.37% |
Diastereoisomer ratio | The ratio of cefuroxime axetil diastereoisomer A to the sum of the cefuroxime axetil diastereoisomers A and B is: 0.48 〜0.55 | 0.52 |
Assay |
745〜875u g/mg (c16h16n4o8s) (calculated on the anhydrous basis)
|
812 u g/mg |
Conclusion | The results conform with USP. |