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| Délai de livraison: | 1 jours |
|---|
Modèle: PH-KZL-082
Tests and Methods |
Specifications |
Results |
Appearance |
White or slightly yellowish,crystalline powder. |
Conforms |
Identification |
|
|
(1) HPLC |
The retention time of the major peak in the chromatogram of Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay |
Identical |
(2) IR absorbance Spectrum |
Both the test sample and the reference standard exhibit the same intensity of absorption at the same wave number(wavelengths). (potassium bromide disk method) |
Identical |
Optical rotation |
-60° to -70° (anhydrous substance). |
-62.56° |
Water |
N.M.T. 0.5% |
0.09% |
residue on ignition |
N.M.T. 0.5% |
0.35% |
Purity |
|
|
1) Related Substances |
Impurity A: N.M.T. 1.5% Impurity B: N.M.T. 0.5% Any other impurity: N.M.T. 0.9% N.M.T one Impurity more than 0.5% Total Impurities: N.M.T. 1.5% |
Not detected Not detected Not detected Conforms Not detected |
2) Residual solvents |
Ethyl acetate: N.M.T. 0.5% N-heptane:N.M.T. 0.5% Acetone: N.M.T. 0.5% n-Hexane: N.M.T. 0.029% |
0.2180% 0.0118% Not detected Not detected |
Assay |
95.0~102.5% ( anhydrous and solvent free basis) |
99.9% |
Conclusion: conforms to the requirements of EP7.0 | ||
Groupes de Produits : API > Antinéoplasique
