| Function: | Respiratory System Agents |
|---|---|
| Grade Standard: | Medicine Grade |
| Type: | API |
| State: | Granulated Powder |
| Volatile: | Not Volatile |
| Stocks: | Customized Products |
| Samples: |
|---|
Suppliers with verified business licenses
Audited Supplier 
| Product Name: | Cefuroxime Axetil (DC GRADE) | ||
| Parameter | Specification | Results | |
| Characters | |||
| Appearance | White to yellowish granulated powder. | Complies | |
| Identification | |||
| Cefuroxime axetil | The principal peaks in the chromatogram obtained with the test solution are similar in retention time to that obtained with reference solution (d). | Complies | |
| Tests | |||
| Related substances | Impurity A ( Δ3 -isomer) : n.m. t. 1.5% | 0.15% | |
| Impurity B ( E-isomer) : n. m. t. 1.0% | 0.26% | ||
| Impurity D CCefuroxime) : n.m. t. 0.5% | 0.04% | ||
| Impurity E CDCC lactone) : n.m.t. 0.5% | Not detectable | ||
| Individual non-specified impurity : n.m.t. 0.10% | 0.04% | ||
| Total impurities: n. m. t. 3.0% | 0.55% | ||
| Diastereoisomer ratio | 0.48~0.55 | 0.53 | |
| Water | n.m. t. 4.0% | 2.8% | |
| Dissolution rate | At 15min not less than 50%. | 58% | |
| At 45min not less than 65%. | 73% | ||
| Assay | |||
| (% w/w)By HPLC, % w/w as Cefuroxime on as is basis | 58.0%-61.5% | 60.2% | |
| Customized products | |||
| Product Name: | Cefuroxime Axetil Amorphous | |
| TESTS | SPECIFICATIONS | RESULTS |
| Characters | A white to almost white powder | A white powder |
| Identification | A.IR,infrared absorption spectrogram of the test solution is similar to that of the reference solution. | conforms |
| B.Examine the chromatograms obtained in the assay; Results:the principal peaks in the chromatogram obtained with the test solution are similar in retention time and size to the peaks due to cefuroxime axetil diastereoisomers A and B in the chromatogram obtained with reference solution(d) |
conforms | |
| Crystallinity | Not show birefringence and extinction positions | conforms |
| Water | ≤1.05% | 0.33% |
| 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 |
| Related substances | Methoxyiminofuranyl acetic acid≤0.3% | <Integral threshold 0.02% |
| Cefuroxime≤0.5% | 0.09% | |
| Cefuroxime lactone≤0.30% | <Integral threshold 0.02% | |
| Cefuroxime axetil delta-3 isomers≤1.2% | 0.10% | |
| Cefuroxime axetil E-isomers≤1.0% | 0.23% | |
| Cefuroxime axetil dimer≤0.5% | 0.13% | |
| Any other individual impurity≤0.30% | <Integral threshold 0.02% | |
| Total impurities≤3.0% | 0.55% | |
| Residual solvents | Acetone≤0.5% | 0.1% |
| Ethyl acetate≤0.5% | 0.06% | |
| N.N-dimethylacetamide≤0.109% | 0.0313% | |
| Isopropyl alcohol≤0.5% | 0.03% | |
| Assay | 745~875μg/mg(C16H16N4O8S)(calculated on the anhydrous basis) | 829μg/mg |
| Conclusion | The results conform with USP Specifications | |
Suppliers with verified business licenses
Audited Supplier 
){kind=link}
){kind=link}