CAS number: 92665-29-7
Molecular formula: C18H19N3O5S
molecular weight: 389.4256
Chemical structure:
Product Name | CEFPROZIL(USP36) |
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Shelf Life |
2 years |
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TEST | SPECIFICATIONS | RESULT |
Description | A white to almost white powder or crystalline powder | Almost white crystalline powder |
Identification |
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- 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. |