Function: | Antineoplastic |
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Grade Standard: | Medicine Grade |
Type: | Chemical Reagent |
State: | Powder |
Volatile: | Not Volatile |
Shelf Life: | 3 Years |
Samples: |
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Items | Standard | Results |
Description | Yellow or orange cryptocrystalline powder. Hygroscopic. | Conforms |
Identification | A. IR-spectrum B. UV-spectrum should have 3 maximums by wavelengths 258 nm, 302 nm and 371 nm.Relation of optical density by 302 nm and 371 nm from 2,8 till 3,3 |
Conforms |
Water | Not more than12.0% | 10.1% |
Residue on ignition | Not more than 0.1% | 0.02% |
Chromatographic purity | Total: Not more than 2.0% | 0.7% |
Individual: Not more than 0.5% | 0.32% | |
Specific rotation | Between +19°to +24° | +19.7° |
Residual solvents | Ethanol : not more than 2000ppm Acetone : not more than 1000ppm Ether: not more than 500 ppm |
100ppm 80ppm 0ppm |
Heavy metals | Not more than 20 ppm | Conforms |
Microbiological purity: - Total count of aerobes in 1 gr - Total count of fungus in 1 gr - Escherichia coli in 1 gr |
103 CFU 102 CFU Absence |
Conforms Conforms Conforms |
Storage conditions | In the protected from light and moisture place, under temperature not higher than 25 oC | Conforms |
Assay | Between 98.0% to 102.0% | 99.3% |
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