| Customization: | Available |
|---|---|
| CAS No.: | 119302-91-9 |
| Formula: | C32h53brn2o4 |
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| Items | Requirements | Result |
| Appearance | White or almost white crystalsorcrystaline powder | Conform |
| Solubility | freely soluble in water and inanhydrous ethanol | Conform |
| Identificatio | A:Specific opticail rotation | Conform |
| B:IR: The same to check sample | Conform | |
| C:gives reaction of bromides | Conform | |
| Appearance of solution | Conforms | Conforms |
| Specific optical rotation | +28.5ºC~+32ºC | +31.2ºC |
| PH | 8.9 to 9.5 for solution S | 9.20 |
| Chlorides | ≤0.10% | 0.06% |
| Related substances | Impurity A≤0.20% | ND |
| Impurity B≤0.20% | 0.061% | |
| Impurity C≤0.20% | 0.027% | |
| Impurity F≤0.15% | 0.0040% | |
| Impurity G≤0.15% | ND | |
| Impurity H ≤0.15% | 0.0048% | |
| Total impurities≤1.0% | 0.15% | |
| Any other impurity≤ 0.1% | 0.032% | |
| Residual solven | A: Methylene chlorid e ≤0.06% | 0.007% |
| B: Aceton e ≤0.50% | 0.23% | |
| C:Acetonitril e≤0.041% | 0.0039% | |
| D:MBTE≤0.50% | 0.06% | |
| E:Ethy l ether≤0.50% | 0.08% | |
| F:Methano l≤0.50% | 0.0052% | |
| Water | ≤4.0% | 2.3 % |
| Sulphated ash | ≤0.1 | 0.068% |
| Endotoxin | <0.30EU/mg | < 0.30EU/mg |
| Assay | 99.0%~101% | 99.96% |
| Conclusion | CONFORM WITH SPECIFICATION AS PER EP10.0. | |
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