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Gemcitabine
| ITEMS | LIMIT |
| Characteristics | White to almost white powder |
| Identification | The IR spectrum is concordant with the reference standard of Gemcitabine Hydrochloride |
| Residue on ignition | ≤0.1% |
| Heavy metals | ≤10ppm |
| Impurity | |
| Gemcitabine α-anmor | ≤0.1% |
| Cytosine | ≤0.1% |
| Individual impurity | ≤0.3% |
| Total impurity | ≤0.5% |
| Assay | 97.5%~101.5% |
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