Function: | Antineoplastic |
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Grade Standard: | Medicine Grade |
Type: | Chemical Reagent |
State: | Powder |
Volatile: | / |
Transport Package: | Bag |
Samples: |
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Acceptance criteria | Results | |
Description | white or light pink powder | light pink powder |
Identification | IR:IR Spectrum of sample is the same as working standar | identical |
HPLC:The retention time of the major peak of the sample corresponds to that of the standard solution | identical | |
Loss on drying | ≤0.5% | 0.3% |
Residual solvent | Ethyl acetate:≤0.5% | 0.2% |
DMSO:≤0.5% | 0.2% | |
Ethanol:≤0.5% | 0.1% | |
Microbial limit | Bacterial counts≤1000/g | 500/g |
Mycetes and yeast≤100/g | 50/g | |
E.Coli:not detected | ND | |
Water | ≤0.4% | 0.2% |
Residue on lgnition | ≤0.1% | 0.1% |
Heavy metals | ≤10ppm | 3ppm |
2-Azahypoxanthine | ≤0.1% | 0.1% |
Temozolomide related compound A | ≤0.1% | 0.05% |
Temozolomide Acid | ≤0.1% | 0.04% |
Dacarbazine related compound A | ≤0.1% | 0.05% |
Cyanotemozolomide | ≤0.1% | 0.05% |
Any unspecified impurity | ≤0.1% | 0.1% |
Total impurities | ≤0.5% | 0.3% |
Assay | 98.00-102.00% | 99% |
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