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nouveaux produits
Délai de livraison: | 3 jours |
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Modèle: USP29
Test Item |
Specifications |
Result |
Discription: |
White or yellowish white crystalline powder, hygroscopic |
white powder |
Solubility |
Freely soluble in water |
Complies |
Identification |
A: IR spectrum: The IR-spectrum of the substance under the provision of strips of absorption has to correspond to a spectrum of vincristine sulfate RS |
Complies |
B: Quality reaction for sulfates: Positive |
Complies |
|
Clarity |
A solution of 25 mg of substance in 5ml of water should be transparent |
Complies |
Color of solution: |
A solution of 25 mg of substance in 5ml of water should be compared with the Y7 |
Complies |
pH |
3.5~5.0 |
3.9 |
Related Substances (HPLC) |
A: Any individual impurity ≤1.0% B: Total impurities ≤3.0% |
0.80% 1.4% |
Residual Solvent
|
A. Methanol: ≤3000ppm B. Ethanol: ≤5000ppm C. Chloroform: ≤60ppm |
<1ppm 1132ppm 45ppm |
Loss on drying |
≤ 15% |
10.5% |
Bacterial Endotoxins |
≤ 10.0EU/mg |
Complies |
Total of aerobic bacterial and fungi |
≤ 100CFU/g |
<10cfu/g |
Enterobacteriaceae |
Should be absent per g or ml |
Not Found |
Pseudomonas aeruginosa |
Should be absent per g or ml |
Not Found |
Staphylococcus aureus |
Should be absent per g or ml |
Not Found |
Assay(HPLC) |
96.0%~102.0%(on anhydrous basis) |
97.40% |
Conclusion: Complies with all requirements of the USP29standards of Vinblastine Sulfate | ||
Storage: Preserve in tight, light-resistant containers, and store in a freezer. |
Groupes de Produits : API > Antinéoplasique