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Specifications:
It usually exists as a white to off - white lyophilized powder or a colorless to slightly yellow - colored liquid in solution form after reconstitution. The powder is stable for storage under appropriate conditions and can be easily dissolved for use.
Identification of urokinase involves various methods. Biochemical assays can detect its specific enzymatic activity related to its thrombolytic function. High - performance liquid chromatography (HPLC) is used to analyze its purity and confirm its identity by separating and quantifying different components. Additionally, immunological methods such as enzyme - linked immunosorbent assay (ELISA) can be applied to detect urokinase - specific antibodies and further verify its authenticity.
Enzymatic Activity: Urokinase's thrombolytic activity is a crucial quality parameter. The specific activity is carefully measured and standardized, usually expressed in international units (IU) per milligram of protein. High - quality urokinase has a consistent and high level of enzymatic activity to ensure effective clot - dissolving performance.
Purity: Purity is strictly controlled, with a high - grade product typically having a purity of 95% or higher. Impurities in urokinase can affect its safety and efficacy, so rigorous purification processes are carried out during production.
Endotoxin Level: Since it is used in medical treatments, the endotoxin level in urokinase is strictly regulated. The acceptable endotoxin content is extremely low (usually expressed in endotoxin units per dose) to prevent potential pyrogenic reactions in patients.
Residual Solvents and Impurities: Limits are set for residual solvents used in the production process and other impurities. These should be within safe levels to ensure the product's quality and patient safety.
Urokinase is mainly used in clinical medicine for thrombolytic therapy. It can dissolve blood clots by activating plasminogen to plasmin, which then breaks down fibrin in clots. It is applied in the treatment of various thrombotic diseases, such as acute myocardial infarction, pulmonary embolism, and deep - vein thrombosis, helping to restore blood flow and reduce the risk of tissue damage caused by clot - obstruction.