ITEM | STANDARD | RESULTS |
Appearance | White or almost white crystalline powder | White crystalline powder |
Dissolution | Easily solubale in water, solubale in 95% alcohol | Complies |
Indentification | (1) Should be positive respond (2) IR graphs should be conforms to the reference standard |
Complies |
pH | 7.0~9.0 | 7.94 |
Clarity | should be not more than 1# working standard solution | Complies |
Color | Should be lighter than the standard solution | Complies |
Optical transmission | Not less than 95% | 99.2% |
Water | 19.0~21.0% | 19.66% |
Chlorides | Not more than 0.01% | Complies |
Sulfates | Not more than 0.05% | Complies |
Residual organic solvents | Not more than 0.3% of methanol Not more than 0.5% ofethanol |
Not detected 0.35% |
Sulfated ash | Not more than 0.1% | Complies |
Relative substance | Total impurity not more than 0.5% | 0.055% |
Heavy Metal | Not more than10ppm | Complies |
Microbiological quality | Should meet the requirements | Complies |
Bacterial endotoxins | Not more than 0.35 IU/mg | Complies |
Assay | No less than 99.0% and not more than 101.0% of C6H14N2O2 2H2O | 99.89% |
Conclusion | The product complies to Enterprise standard |