CAS No:122111-03-9
MF:C9H11F2N3O4·HCl
Shelf life:2 years
The detailed specifications are as below:
| Items | Standard |
| Characteristics | White crystalline powder,odorless |
| Solubility | Soluble in water,slightly soluble in methanol,practically insoluble in acctone |
| Specific rotatory power | +43°~+50° |
| Appearance of solution | Solution S in clear and not more intensely colored than reference solution BY7 |
| Identification | a)IR:Concordant with R.S |
| b)CHLORIDE | |
| Acidity(PH) | 2.0~3.0 |
| Cytosine | ≤0.1% |
| Gemcitabine ɑ-anomer | ≤0.1% |
| Any individual unspecified impurity | ≤0.1% |
| Total impurities | ≤0.2% |
| Residue on ignition | ≤0.1% |
| Residual solvents | Methanol≤0.03% |
| Acetone≤0.5% | |
| Heavy metals | ≤10ppm |
| Bacteria | <50cfu/g |
| Mold, Yeast | <20cfu/g |
| E. Coli | No detected |
| Bacterial endotoxins | <0.05EU/mg |
| Assay(calculated on the as-is basis) | 97.5%~101.5% |