Vinorelbine Tartrate with GMP 125317-39-7 NVB Best Quality in China
Basic Info
Model No.: USP35
Product Description
Test Item | Specifications | Result |
Apperance | White to yellow or light brown, amorphous powder | white powder |
Solubility | Freely soluble in water | Complies |
Color of solution | The solution is clear | Complies |
Identification A: Infrared absorption B: RT of main peak C: Reaction of tartrates | Complies to the reference standard Complies to the reference standard Positive | Complies Complies Complies |
pH | 3.3 ~ 3.8 | 3.4 |
Residue on ignition | ≤0.1% | 0.01% |
Water | ≤4.0% | 2.2% |
Related Substances 3,6-Epoxy vinorelbine Vinorelbine Impurity A Any individual impurity Total impurities |
≤0.3% (3,6-Epoxy vinorelbine) ≤0.2% (Vinorelbine Impurity A) ≤0.2% (Any individual impurity) ≤0.7% (Total impurities) | Not found Not found 0.06% 0.2% |
Residual Solvent
Acetone Methanol Methylene chloride Chloroform Tetrahydrofuran Ethanol | ≤0.5% ≤0.3% ≤0.006% ≤0.072% ≤0.5% ≤0.5% |
0.354% 0.045% 0.0004% Not found Not found 0.037% |
Microbial Limit Bacteria Fungi Escherichia coli |
≤800cfu/g ≤80cfu/g Not Found/g |
20cfu/g 20cfu/g Not Found/g |
Assay | 98.0%~102.0% | 99.8% |
Conclusion: Complies with all requirements of the USP35 standards of Vinorelbine Tartrate |
Product Categories : API > Antineoplastic