CAS number： 50915-40-5
Molecular formula： C22H36N2O5S.HCl.H2O
molecular weight： 495.08
Chemical structure：
| Items | Specifications | Results | ||
| Appearance | white or almost white powder，odorless，freely soluble in methanol and alcohol， slight soluble in water. 0.1mol/l hydrochloric acid and 0.1mol/l sodium hydroxide | Complies | ||
| Identification | UV Complies | Complies | ||
| IR Complies | Complies | |||
| Related substance | Single impurity | ≤0.1% | 0.080% | |
| Total impurity | ≤0.3% | 0.192% | ||
| Specific rotation | -13.5°~-16.5° | -16.4° | ||
| PH | 2.4-3.4 | 2.9 | ||
| Isomer | ≤0.5% | 0.05% | ||
| Clarity of solution | Clarity | Complies | ||
| Residual solvent | Acetic acid | ≤0.5% | 0.144% | |
| ethyl acetate | ≤0.5% | 0.042% | ||
| methanol | ≤0.3% | No detected | ||
| cyclohexane | ≤0.388% | No detected | ||
| acetonitrile | ≤0.041% | No detected | ||
| MTBE | ≤0.5% | No detected | ||
| Pyridine | ≤0.02% | No detected | ||
| dimethyl sulfoxide | ≤0.5% | No detected | ||
| Water | 3.0%-4.5% | 3.50% | ||
| sulphated ash | ≤0.1% | 0.052% | ||
| Heavy metals | ≤10ppm | Complies | ||
| Pd | ≤1ppm | No detected | ||
| Microbial limit | Complies | Complies | ||
| Bacterial endotoxin | ≤10EU/mg | Complies | ||
| Assay on dried | 98.0%~102.0% | 99% | ||
| Conclusion | Complies with the requirement of In-home standard | |||
