| Test Items |
Specifieation |
Results |
| Appearance |
Light brown to colorless liquid |
Conforms |
| Concentration |
25.0±2.5mg/ml |
26.5mg/ml |
| Non-reduced CE-SDS |
Main peak ≥ 90.0% |
98.6% |
| SEC-HPLC |
Main peak ≥ 95.0% |
99.2% |
| Isoelectric Point |
Corresponds to reference standard |
Conforms |
| Bacterial endotoxins |
≤ 30EU/mg |
Conforms |
| Residual proteins of host cell |
≤ 100ng/mg |
1ng/mg |
| Exogenous residual DNA |
≤ 100pg/mg |
1pg/mg |
| Residual protein A |
≤ 100ng/mg |
1ng/mg |
| Biological Activity |
Compared with standard, the range of biological activity is from 80% to 125% |
101.0% |
| Osmolality |
Corresponds to reference standard |
Conforms |
| Peptide mapping |
Corresponds to reference standard |
Conforms |
| N-terminal sequence |
Corresponds to reference standard |
Conforms |