Crude Urokinase|UK-150407-07
Certificate of Analysis
Product: | Crude Urokinase (semi-purified urokinase) | Lot No.: | UK-150407-07 |
Net vol: | 15030 ml | Amount: | 7500 MIU |
Manufacture date: | 2015-04-08 | Test date: | 2015-04-14 |
Test Items | Specifications | Results |
Appearance | Pale yellow and clear solution | Pale yellow and clear solution |
Appearance after dissolved | Pale yellow and clear solution | Pale yellow and clear solution |
Electric conductivity | 16500-17500 us/cm | 16600 us/cm |
Microbial count | NMT 100 cfu/ml | < 10 cfu/ml |
Pyrogen (20000 IU/ml.kg.rabbit) | T.R. ≤ 1.15℃, M.R. ≤ 0.5℃ | Pass |
Endotoxin | N.M.T 2 EU/20000 IU | 0.80 EU/20000 IU |
Abnormal toxicity (2500 IU/0.5ml/mouse) | Free from abnormal toxicity | Pass |
Potency | 300000-600000 IU/ml | 499075.2 IU/ml |
Specific activity | N.L.T 100000 IU/mg.pr | 138632 IU/mg.pr |
Molecular fraction | N.L.T 90% of the urokinase (M.W. 54000) | 95 % |
Super macromolecule | None | Pass |
Protein | Value on determination | 3.6 mg.pr/ml |
pH | 3.9-4.2 | 4.0 |
HBs-Ag | Negative (50000 IU/ml) | Negative |
Anti-HCV | Negative (50000 IU/ml) | Negative |
Anti-HIV 1/2 | Negative (50000 IU/ml) | Negative |
Inspector | Re-checker |