Item | Specification |
Description | White or almost white crystalline powder |
Identification | Specific optical rotation: -12.0°to -9.0°(dried substance)IR: Complies with the reference standard. |
Appearance of solution | Not more intensely coloured than reference solution Y7 |
PH | 7.0~9.0 |
Related substances | |
Impurity A | ≤0.2% |
Impurity B | ≤0.2% |
Impurity C | ≤0.2% |
Impurity D | ≤0.2% |
Any other impurity | ≤0.2% |
Total impurity | ≤0.5% |
Loss on drying | ≤0.5% |
Sulfated ash | ≤0.1% |
Assay | 99.0% ~ 101.0% |
Sum of residual Ethanol and Isopropanol | ≤0.5% |