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100 Gram |
Negotiable |
oxaliplatino oxaliplatino API oxaliplatin
99%min we have GMP
Oxaliplatin
Appearance |
White or almost white crystalline powder. |
Solubility |
slightly soluble in water, very slightly soluble in methanol, practically insoluble in ethanol. |
Identification |
A. Infrared absorption spectrum |
|
B. It complies with the test for specific optical rotation (see Tests). |
Appearance of solution |
The solution is clear and colourless. |
Acidity |
The solution is colorless, and NMT 0.6ml of 0.01M sodium hydroxide is required to change the color to pink. |
Specific optical rotation |
+74.5°~+78.0° |
Content of Platinum |
48.1%~50.1% of the Oxaliplatin taken, on the dried basis |
Related substances |
Impurity A≤0.1% |
|
Impurity B≤0.1% |
|
Impurity C≤0.1% |
|
Any other impurity ≤0.1% |
|
Total of other impurities ≤0.1% |
|
Total impurities(the sum of impurities A, B, C and other related impurities) ≤0.30% |
|
Impurity D≤0.1% |
Silver |
≤5.0ppm |
Loss on drying |
≤0.5% |
Bacterial endotoxins Test |
≤1.0IU/mg of Oxaliplatin |
Assay |
98.0 per cent to 102.0 per cent (dried substance). |
Microbial Enumeration Tests and Tests and for Specified Microorganisms |
Total aerobic microbial count ≤20CFU/g |
|
Total combined molds and yeast count≤5CFU/g |
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