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CAS 103639-04-9 Ondansetron Hydrochloride Ondansetron Hcl | ||
Name | Ondansetron | |
Synonyms | 1,2,3,4-Tetrahydro-9-methyl-3-(2-methyl-1H-imidazol-1-ylmethyl)carbazol-4-one | |
Molecular Formula | C18H19N3O | |
Molecular Weight | 293.37 | |
CAS Registry Number | 99614-02-5 (116002-70-1) |
Test items | Standard | Test results |
Description | White or almost white crystalline powder | white crystalline powder |
Solubilit | Slightly soluble in water ,very slightly soluble in methanol, practically insoluble in ethano | Complies |
Identificatio | IR vs standard | Complies |
Test for specific optical rotation | Complies | |
Appearance of solution | The solution is clear and colorless | Complies |
Acidity | Not more than 0.6ml of 0.01M Naoh is required to change the color of the indicator to pink | 0.44ml |
Specific optical rotatio | +74.5°~+78.0° | +75.6° |
Related substances | ImpurityA:NMT0.1% | 0.03% |
Impurity B: NMT0.1% | 0.05% | |
Impurity C: NMT0.1% | 0.03% | |
Any other impurity:NMT0.1% | 0.05% | |
Total of other impurities:NMT0.1% | 0.06% | |
Total of impurities:NMT0.3% | 0.16% | |
Impurity D | NMT0.1% | 0.01% |
Loss on drying | NMT0.5% | 0.19% |
Assay | 98~102% (dried substance) | 99.85% |
Bacterial endotoxins | <1.0IU/mg | Complies |
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