| Function: | Respiratory System Agents |
|---|---|
| Grade Standard: | Medicine Grade |
| Type: | Chemical Reagent |
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| Name of product | Sulbactam Pivoxil | |
| Tests | Specifications | Results |
| Appearance | A white to yellowish powder or crystallization | A white powder |
| Melting point | 102.0ºC~106.0ºC | 104.0ºC~105.0ºC |
| Specific optical rotation | +167.0°~+175.0° | +171.3° |
| Identification | (1)The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the standard preparation,as obtained in the Assay | Conforms |
| (2)The IR spectrum obtained with the substance to be examined corresponds with that obtained with reference standard |
Conforms | |
| Water | ≤1.0% | 0.029% |
| Related substances | Total impurities≤3.0% | <Reporting threshold limit 0.05% |
| Residue on ignition | ≤0.2% | 0.07% |
| Heavy metals | ≤20ppm | <20ppm |
| Residual Solvents | Ethanol≤0.5% | 0.01% |
| Acetone≤0.5% | <0.005% | |
| Ethyl acetate≤0.5% | 0.01% | |
| Methylene Chloride≤0.06% | <0.006% | |
| N,N-Dimethylformamide≤0.088% | <0.0088% | |
| Assay | ≥65.0% Sulbactam(C8H11NO5S)(calculated on the anhydrous bssis) | 67.1% |
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