| Item | Specification | Results |
| Appearance | White or off-white powder | White powder |
| MS | 1632.3 ± 1.0 | Complies |
| HPLC |
The principal peak in the chromatogram obtained with the test solution is similar in retention time to
principal peak in the chromatogram obtained with the reference solution. |
Complies |
| Solubility | Soluble in water and 1% acetate acid | Complies |
| Water | NMT 7 .0% | 3.9 % |
| Related Substances | Any individual impurity NMT 1.0 % | 0.25 % |
| Total impurity NMT 2 .0% | 0.6 % | |
| Purity (HPLC) | NLT98.0% | 99.4 % |
| Acetic acid | NMT6.8% | 3. 6 % |
| Bacterial Endotoxins | LT5IU/mg | Complies |
| Peptide content(N%) | NLT80% | 91.1% |
| Assay | 97.0%~103.0%(anhydrous and acetic acid free substance) | 98.5% |
| Conclusion | The test results conform to above standard. | |
| Storage | Storage in an air tight container, protected from light at a temperature of 2-8ºC. | |
|
The End |