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CAS number： 92665-29-7
Molecular formula： C18H19N3O5S
molecular weight： 389.4256
Chemical structure：
| Product Name | CEFPROZIL（USP36） |
|
| Shelf Life |
2 years |
|
| TEST | SPECIFICATIONS | RESULT |
| Description | A white to almost white powder or crystalline powder | Almost white crystalline powder |
| Identification |
|
|
| - By IR | The Infrared absorption spectrum of the potassium bromide dispersion of the sample must be concordant with that of a similar preparation of cefprozil(Z)-isomer working standard/reference standard. | Complies |
| - By HPLC | The retention times of the cefprozil(Z)-isomer and cefprozil(E)-isomer peaks in the chromatogram of the Assay preparation correspond to those of the Standard preparations, as obtained in the Assay. | Complies |
| Crystallinity | Should be crystalline | crystalline |
| PH | 3.5 ～ 6.5 | 4.38 |
| Water | 3.5% ～ 6.5% | 4.87% |
|
Related compounds Cefadroxil -Individual -Total impurities |
≤ 0.5% ≤ 0.5% ≤ 1.5% |
0.16% ND ND |
| Cefprozil (E)-isomer ratio | 0.06～0.11 | 0.074 |
|
Assay (By HPLC,w/w) (Contains C18H19N3O5S, Calculated on the anhydrous basis) |
900ug/mg～1050ug/mg | 992.7ug/mg |
|
REMARKS: The material complies as per above specifications. |
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