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 |