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          | Active Pharmaceutical Ingredient |  
        
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                    |  |   | Product Name: Gemcitabine Hydrochloride CAS NO.: 95058-81-4
 Description:
 
| Items | Specification |  
| Appearance: | White crystalline powder. |  
| Identification: IR Chloride |   Concordant with R.S   |  
| Solubility | Meet USP28 |  
| Specific rotation: | +43 to +50 |  
| pH value(in 1% solution): | 2.0-3.0 |  
| Cytosine | Not more than 0.1% |  
| ¦Á-anomer | Not more than 0.1% |  
| Sum of impurities | Not more than 0.2% |  
| Loss on drying: | Not more than 1.0% |  
| Residue on Ignition: | Not more than 0.1% |  
| Heavy metals (Pb): | Not more than 10ppm |  
| Assay (by HPLC): | 97.5-101.5% |  |  |  
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