Urokinase|UK-170202-02
CERTIFICATE OF ANALYSIS
Product | Urokinase | Lot No. | UK-170202-02 |
Gross Weight | —— | Mfg date | 2017-02-08 |
Net Weight | 95.33 g | Exp date | 2019-02-07 |
Total activity | 10270 MIU | Test date | 2017-02-24 |
Test Items | Specifications | Results | |
Visual appearance | White to light yellow powder | White powder | |
Identification | Positive | Conforms | |
PH | 4.0-7.5 (1mg/ml) | 6.3 | |
Endotoxin | ≤ 2 EU/20,000IU Urokinase | Conforms | |
HIV I+II | Negative (1,000 IU/ml) | Negative | |
HCV antibodies | Negative (1,000 IU/ml) | Negative | |
HBs-Ag | Negative (1,000 IU/ml) | Negative | |
HIV (PCR) | Negative (10,000 IU) | Negative | |
HCV (PCR) | Negative (10,000 IU) | Negative | |
HBs (PCR) | Negative (10,000 IU) | Negative | |
Molecular fractions | N.L.T 85 % of the urokinase (M.W. 54000) | 86.5% | |
Potency | ≥ 75,000 IU/mg | 107731.6 IU/mg | |
Specific activity | N.L.T 100,000 IU/mg.pr | 160793.4 IU/mg.pr | |
Conclusion | Conformly to consult specification | ||
Analyst | Checker | Supervisor of QA |