Parameters Specifications DS (from 200L) DS (from 2000L)
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