Temozolomide
Test items | Requirements | Results |
Description | A White or off-white crystalline powder; odorless; tasted bitter. | Complies |
Solubility | Slightly soluble in water, very slightly soluble in dehydrated alcohol, soluble in DMF and very soluble DMSO. | Complies |
Identification |
| |
A. IR | A: Conform to reference standard | Conforms |
B. Chemical Property | B: Dissolve 0.1g the sample with 10ml water, add 5ml dinitro-phenyl-hydrazine, should have marron precipitate. | Positive |
C. HPLC | C: The retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation | Conforms |
Loss on drying | ≤ 1.0%. | 0.21% |
Residue on ignition | ≤ 0.1%. | 0.07% |
Heavy metals | ≤ 0.002%. | Complies |
Chloride | ≤ 0.002%. | Complies |
Impurities by HPLC Any impurity(Max) Total impurities | ≤ 0.1%. ≤ 0.3%. |
0.042% 0.08% |
Residual solvents Ethyl acetate Alcohol DMSO | ≤ 0.5%. ≤ 0.5%. ≤ 0.5%. |
Complies Complies Complies |
Assay (HPLC) | 98.5%~102.0% | 99.80% |
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Temozolomide