Vincristine Sulfate with GMP 2068-78-2 Best Quality in China
Basic Info
Model No.: USP35
Product Description
Test Item | Specifications | Result |
Apperance | White to slightly yellow, odorless, amorphous or crystalline powder | white powder |
Solubility | Freely soluble in water, soluble in methanol, slightly soluble in ethanol. | Complies |
Identification A: Infrared absorption B: Sulfate | Complies to the reference standard Corresponding to the test for sulfate | Complies Complies |
pH | 3.5 ~ 4.5 | 4.0 |
Loss on drying | ≤12.0% | 8.6% |
Related Substances Any individual impurity Total impurities | ≤1.0% ≤4.0% | 0.74% 2.2% |
Residual Solvent Ethanol Methanol Acetone Chloroform Benzene |
≤0.5% ≤0.3% ≤0.5% ≤0.006% ≤0.0002% |
0.1% 0.006% 0.001% 0.003% 0.00005% |
Microbial Limit Bacteria Fungi Escherichia coli |
≤500cfu/g ≤50cfu/g Not Found/g |
20cfu/g <10cfu/g Not Found/g |
Assay | 95.0%~105.0% | 98.9% |
Conclusion: Complies with all requirements of the USP35standards of Vincristine Sulfate |
Product Categories : API > Antineoplastic