| Function: | Antineoplastic, Anesthetic and Adjuvant |
|---|---|
| Grade Standard: | Medicine Grade |
| Type: | Chemical Reagent |
| State: | Powder |
| Volatile: | Not Volatile |
| Shelf Life: | 2 Years |
| Samples: |
|---|
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Audited Supplier | item | standard | result |
| appearance | white or almost white crystalline powder | off-white crystalline powder |
| identification | IR:the IR spectrum of the sample is consistent with that of the reference spectrum. | conforms |
| HPLC:the relative retention time of major peak of the sample solution corresponds to that of the standard solution,as obtained in the assay. | conforms | |
| Chloride:It meets the requirements of the tests for chloride | conforms | |
| solubility | soluble in water,slightly soluble in methanol,practically insoluble in ethanol,shloroform or acetone. | conforms |
| specifie rotation | +43°~+50° | +47° |
| acidity | 2.0-3.0 | 2.6 |
| loss on drying | ≤1.0% | 0.14% |
| residue on ignition | ≤0.1% | 0.02% |
| heavy metals | ≤10ppm | conforms |
| related substances | cytosine≤0.1% | 0.0049% |
| gemcitabineα-anomer≤0.1% | 0.0020% | |
| any single unidentified impurity≤0.1% | 0.012% | |
| total impurities≤0.2% | 0.023% | |
| residue solvents | methanol≤0.3% | 0.0018% |
| ethanol≤0.5% | not detected | |
| bacterial endotoxins | <0.05EU/mg (Calculate as Gemcitabine) | <0.03EU/mg |
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Audited Supplier 
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