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| Délai de livraison: | 3 jours |
|---|
Modèle: USP35
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 | ||
Groupes de Produits : API > Antinéoplasique
