| Product Name | Gemcitabine Hydrochloride | ||
| Batch No. | 2017060302 | Date of Test | Jun. 03,2017 |
| Quantity | 10.6KGs | Date of Mfg. | Jun. 03,2017 |
| Standard | EP8.3 | Date of Report | Jun. 02,2018 |
| ITEMS | SPECIFICATIONS | RESULTS | |
| Appearance | White to off-white powder | Conforms | |
| Solubility | Soluble in water, slightly soluble in methanol, practically insoluble in acetone | Conforms | |
| Specific optical Rotation | +43º~+50º | +48.0º | |
| Identification | A | Infrared absorption spectrophotometry (2.2.24) comparision Gemcitabine Hydrochloride CRS | Conforms |
| B | It gives reaction (a) of chloride (2.3.1) | Conforms | |
| Appearance of solution | Solution Sample in clear(2.2.1) and not more intensely | Conforms | |
| pH | 2.0~3.0 | 2.2 | |
| Related substances | Impurity A: ≤0.15% Impurity C: ≤ 0.2% Unspecified impurities: ≤ 0.1% Total impurities: ≤ 0.4% |
0.001% Not detected 0.03% 0.03% |
|
| Heavy metals | ≤ 10ppm | Conforms | |
| Sulphated ash | ≤ 0.1% | 0.03% | |
| Residual solvents | Methanol: ≤ 0.3% Acetone: ≤ 0.5% |
Not detected 0.1% |
|
| Assay | 97.5%~101.5% | 99.1% | |
| Bacteria | < 50cfu/g | < 10cfu/g | |
| Yeast and Mold | < 20cfu/g | < 10cfu/g | |
| E. coli | No detected. | No detected | |
| Conclusion | The above product complies with the standard of EP8.3. | ||
