Appearance |
Practically free from visible particles |
Practically free
from visible particles |
Practically free from visible
particles |
Clarity and Degree of Opalescence (NTU) |
NMT 18 NTU |
5 |
3.4 |
Degree of coloration |
Not more intensely colored than Reference
Solution Y5 |
<Y6 |
<Y5 |
pH |
5.0 -6.0 |
5.6 |
5.5 |
Osmolality |
250 -400 mOsmol/Kg |
310 |
320 |
Protein concentration |
18-22mg/mL |
20.6 mg/mL |
19.8
mg/mL |
Biological activity (ELISA) |
70-130 % of Ref. STD |
95% |
105% |
Purity (Reduced CGE-SDS) |
NLT 85 % |
95.3% |
96.2% |
LMW (Non-Reduced CGE-SDS) |
NMT 12 % |
8.3% |
7.5% |
% Purity by iCE
|
CPI Cluster 3 (Main Peak): 97-103 %
Acidic cluster: Report Result
Main Peak: Report Result
Basic Cluster: Report Result
|
CPI%=100
Acidic Cluster: 51.0%
Main Peak: 39.1 %
Basic Cluster: 9.9%
|
CPI%=100
Acidic Cluster: 49.4%
Main Peak: 40.5 %
Basic Cluster: 10.1%
|
HMW species (SE-HPLC) |
NMT 6.5 % |
4.3% |
3.8% |
Residual HCP |
NMT 30 ng/mg |
1.794 ng/mg |
< 0.303
ng/mg |
Residual DNA |
NMT 5 pg/mg |
<0.421 pg/mg |
<0.22
pg/mg |
Residual Protein A |
NMT 30 ng/mg |
< 0.311 ng/mg |
< 0.8 ng/mg |
Bioburden |
NMT 1 CFU/10mL |
0 CFU/ 10 mL |
0 CFU/ 10 mL |
Bacterial Endotoxin Test (BET) |
NMT 0.1 EU/mg |
<0,01 EU/mg |
<0,01 EU/mg |