Trouver Piles Médecine, Pile Cure, Traitement De Pieux dans le répertoire Industry, Reliable Fabricant / Fournisseur / Factory de Chine
nouveaux produits
Délai de livraison: | 3 jours |
---|
Modèle: USP29
Items |
Specifications |
Results |
Description |
White to off-white powder |
White to off-white powder |
Identification: A: Infrared Absorption (IR) B: The retention time (HPLC)
|
Conforms to reference spectrum Conforms to the chromatogram of the Standard preparation |
Conforms Conforms |
Specific rotation á (on the anhydrous, solvent-free basis) |
-49.0° to -55.0° |
-51.17° |
Microbial limits The total aerobic microbial Staphylococcus aureus , Pseudomonas aeruginosa, Salmonella species and Escherichia coli. |
≤100 CFU/g meets the requirements of the tests for the absence |
Not found Not found
|
Bacterial endotoxins |
≤0.4 USP Endotoxin Unit per mg |
Complies |
Water |
≤4.0% |
0.62% |
Residue on Ignition |
≤0.2% |
0.09% |
Heavy Metals |
≤0.002% |
<0.001% |
Related compounds |
|
|
Baccatin III |
≤0.2% |
Less than LOD (0.003%) |
10-Deacetylpaclitaxel |
≤0.5% |
Less than LOD (0.003%) |
7-Xylosylpaclitaxel |
≤0.2% |
Less than LOD (0.003%) |
Cephalomannine 2¢¢,3¢¢-Dihydrocephalomannine |
a1 a2 a1+ a2 ≤0.5 % |
0.11% |
10-Deacetyl-7-epipaclitaxel |
≤0.5% |
Less than LOD (0.003%) |
Benzyl analog3 3¢¢,4¢¢-Dehydropaclitaxel C |
b1 b2 b1+ b2 ≤0.5 % |
Less than LOD (0.003%) |
7-Epicephalomannine |
≤0.3% |
Less than LOD (0.003%) |
7-Epipaclitaxel |
≤0.5% |
0.04% |
Any other single impurity |
≤0.1% |
0.01%,0.006%,0.03%,0.006%,0.04% (RRT=1.24,1.26,1.31,1.41,1.44) |
Total impurities |
≤2.0% |
0.24% |
Organic Volatile Impurities (OVI) |
Meets current USP requirement |
Meets current USP requirement |
Assay (on the anhydrous, solvent-free basis) |
97.0%~102.0% |
100.48% |
Residual Solvents |
|
|
Acetone |
≤2000ppm |
52ppm |
Dichloromethane |
≤100ppm |
20ppm |
Ethyl acetate |
≤1000ppm |
71ppm |
Cyclohexane |
≤1000ppm |
712ppm |
Conclusion: The product Complies with the requirement of USP29 |
Groupes de Produits : API > Antinéoplasique