Item | Specification | Test result |
Characters | A white or almost white crystalline powder | A white crystalline powder |
Infrared spectrum | To match with the working standard | Complies |
Water | Not more than 5.0% | 4.15% |
Residual solvents | Meets the requirements | Complies |
Specific rotation | -40.0° -43.4° | -40.4° |
Related substances | Not more than 2.0% | 1.27% |
Lead | Not more than 2ppm | Complies |
Residue on ignition | Not more than 0.1% | 0.1% |
Assay | 97.0%102.0% | 98.73% |
PH | 5.07.0 | 5.44 |
Melting Point | 8185 | 80.983.4 |
Total Aerobic Bacteria | 250cfu/g | 120cfu/g |
Coliform | 10mpn/g | Complies |
Fungi | 100cfu/g | Complies |
Solubility (25) | 100g per 100g of ethanol | Complies |
1.3g per 100g of water | Complies |