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舒更葡糖杂质CY-3228
毫克
Mono-SO-SGM
N/A
罗辅医药科技（上海）有限公司
-20摄氏度
| Molecular Formula | C72H112-n+3mNmNanO49S8 |
|---|---|
| Formula Weight | 2018 + n·22 + m·17 |
| Solubility (in 100 cm3 solvent, at 25 °C) |
Water: soluble |
| Tests and methods | Requirements |
|---|---|
| Identification 1 LC-MS | conforms to theoretical mass |
| Identification 2 NMR; EP 2.2.33 | conforms to theoretical structure |
| Identification 3 IR; EP 2.2.24 | conforms to theoretical structure |
| Purity as mixture of epimers HPLC1; EP 2.2.29 | >90% |
| Other cyclodextrin-related impurities HPLC1; EP 2.2.29 | <10% |
| Formate content (expressed as Sodium formate) CE; EP 2.2.47 | <3% |
| Sodium content CE; EP 2.2.47 | <10% |
| Ammonium content CE; EP 2.2.47 | <10% |
| Residual solvents TGM-MS | <10% |
| Purity calculated2 | to be reported |
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