產品中心
阿利人單抗
1. Concentration |
150.0±15.0 mg/ml |
151.3 mg/ml |
2. pH value |
Corresponds to reference standard |
Pass |
3. Purity |
|
|
3.1 Non-reduced CE-SDS |
Main peak NLT 90.0% |
98.3% |
3.2 SEC-HPLC |
Main peak NLT 95.0% |
99.2% |
4. Isoelectric Point |
Corresponds to reference standard |
Pass |
5. Bacterial Endotoxins Test |
<15 EU/ml |
1 EU/ml |
6. Residual Proteins of Host Cell |
≤100 ng/mg |
1 ng/mg |
7. Exogenous Residual DNA |
≤100 pg/mg |
<1 pg/mg |
8. Residual protein A |
≤100 ng/mg |
<1 ng/mg |
9. Biological Activity |
Compared with standard, the range of biological activity is from 80% to 125%. |
101% |
10. Osmolality |
Corresponds to reference standard |
Pass |
11. Peptide mapping |
Corresponds to reference standard |
Pass |
12. N-terminal sequence |
Corresponds to reference standard |
Pass |