Function: | Antineoplastic |
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Grade Standard: | Medicine Grade |
Type: | Chemical Reagent |
State: | Solid |
Volatile: | Not Volatile |
Shelf Life: | >2 Years |
Samples: |
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item | standard | result |
appearance | yellow powder,or yellow or orange-yellow crystals | orange-yellow crystals |
identification | the retention time of the major peak in the chromatogram of the assay preparation corresponds to that of the standard preparation as obtained in the assay | conforms |
the infrared absorption spectrum of the substance should correspond to the spectrum of cisplatin reference standard | conforms | |
crystallinity | meets the requirements | conforms |
water | not more than 1.0% | 0.08% |
UV purity ratio | not more than 4.5 | 5.1 |
limit of trichloroammineplatinate(HPLC) | not more than 1.0% | 0.02% |
limit of transplatin (HPLC) | not more than 2.0% | not detected |
platinum content | between 64.42% and 65.22%,on the anhydrous basis | 64.91% |
residual solvents | ethanol:not more than 1000ppm | 56ppm |
ethyl ether:not more than 1000ppm | 0.1ppm | |
benzene:not more than 2ppm | not detected | |
assay | contains not less than 98.0 percent and not more than 102.0 percent of cisplatin,calculated on the anhydrous basis | 99.8% |
bacterial endotoxins | less than 0.86EU/mg cisplatin | <0.86EU/mg |
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