| Customization: | Available |
|---|---|
| Type: | Topiroxostat |
| Appearance: | Powder |
|
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| Item | Limit |
| character |
Appearance:White to pale yellow crystalline powder. |
| solubility: Slightly soluble in dimethyl sulfoxide, slightly soluble in 0.1mol/L hydrochloric acid solution, almost insoluble in methanol, anhydrous ethanol or water. | |
| Identification |
A.In the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with that of the main peak of the reference solution. |
| B.The infrared absorption spectrum of this product should be consistent with the spectrum of the reference substance. | |
| Related substance | Impurity HTRO-B:not more than0.15%. |
| Maximum unknown single impurity:not more than 0.10%. | |
| Total impurity:not more than1.0%. | |
| Residual solvent | Methanol :not more than 0.3%. |
| Ethanol: not more than 0.5%. | |
| Loss on drying | Not more than 1.0%. |
| Residue on ignition | Not more than 0.1%. |
| Heavy metals | Not more than10ppm. |
| Microbial limit | The total number of aerobic bacteria shall not exceed 1000cfu/g. |
| The total number of mold and yeast must not exceed 100cfu/g. | |
| Escherichia coli should not be detected. | |
| Assay | According to the dry product calculation, the content of C13H8N6 should be 98.0% to 102.0% |
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