61825-94-3
Product name: Oxaliplatin
Molecular formula :C8H14N2O4Pt
CAS Registry Number :61825-94-3
Standard: EP7.4/usp35
Appearance: White crystalline powder
Purpose: Anticancer drugs
Product name: Oxaliplatin
Molecular formula :C8H14N2O4Pt
CAS Registry Number :61825-94-3
Standard: EP7.4/usp35
Appearance: White crystalline powder
Purpose: Anticancer drugs
Item |
Acceptance criteria |
Result |
Character |
White or almost white, crystalline powder. |
White crystalline powder |
Solubility |
Slightly soluble in water, very slightly soluble in methanol, practically insoluble in anhydrous ethanol |
Conforms |
Identification |
A:IR spectrum: Spectrum of the sample should be consistent with spectrum of reference standard. B: Specific optical rotation: complies with the test for specific optical rotation |
Conforms
Conforms
|
Appearance of solution |
The solution is clear and colorless |
Conforms
|
Acidity |
Meet the requirement |
Conforms |
Specific Optical Rotation
|
+ 74.5 to + 78.0 (dried substance). |
75.8 |
Related substances |
Impurity A ≤0.1% |
0.01% |
Impurity B≤0.1% |
0.02% |
|
Impurity C ≤0.1% |
0.001% |
|
other related substances≤0.1% |
0.005% |
|
Impurity D≤0.1% |
0.02% |
|
Total impurity≤0.30% |
0.04% |
|
Loss on Drying |
Maximum 0.5 per cent |
0.14% |
Bacterial Endotoxins |
Less than 1.0 IU/mg |
Conforms
|
ASSAY |
98.0%~102%(Dried substance) |
99.4% |
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