China Vincristine Sulfate 2068-78-2, Find details about China Vincristine Sulfate, 2068-78-2 from Vincristine Sulfate 2068-78-2
Items | Standards | Results |
Appearance | White to slightly yellow,amorphous or crystalline powder,odorless,tasteless; easy to moisture absorption | Complies |
Identification | By IR: Complies to the reference standard | Complies |
By Sulfate: Corresponding to the test for sulfate | Complies | |
Solubility | Freely soluble in water, soluble in methanol, slightly soluble in ethanol | Complies |
Loss on Drying | ≤ 12.0% | 7.02% |
Residual Solvents | Ethanol: ≤5000ppm | 1420ppm |
Methanol: ≤3000ppm | 33ppm | |
Acetone: ≤5000ppm | 13ppm | |
Chloroform: ≤60ppm | 7ppm | |
Benzene: ≤2ppm | 0.1ppm | |
Related Substances | Any individual impurity: ≤1.00% | 0.66% |
Total Impurities: ≤4.00% | 1.70% | |
Assay | 95.0%~105.0% | 99.22% |
Microbial Limit | Total number of aerobe: ≤103cfu/g | ≤20 cfu/g |
Mold and yeast: ≤102cfu/g | ≤20 cfu/g | |
Escherichia coli: Not Found | Not Found | |
Reference Standard | USP35 Standard | |
Conclusion | The product complied to USP35 standard. | |
Storage | Preserve in tight,light-resistant containers in a cool place |