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        Urokinase
        CAS No. : 9039-53-6 (Plasminogen activator;fibrinolytic; enzyme)

        Short Description:

        Source: Extracted from fresh male urine
        Function and use: Urokinase is a fibrinolytic drug, which can hydrolyze protein, has no antigenicity, and can directly activate plasminogen. This product is mainly used for the treatment of acute myocardial infarction, acute cerebral thrombosis, cerebral vascular occlusion, peripheral arteriovenous thrombosis, central retinal vein thrombosis and other infarct diseases caused by the formation of new blood clots.

        Urokinase-Pharmacopoeia?Standard:?BP/EP/JP


        Product Detail

        Product Tags

        CAS No.: 9039-53-6
        Complies with?CP2020,?USP43,?JP18, BP2022, EP10.0

        Specification

        Urokinase

        Source Fresh human urine
        Process description This product is an enzyme obtained from fresh human urine that activates plasminogen. It consists of a mixture of low-molecular-mass (LMM) (33 000) and high-molecular-mass (HMM) (54 000) forms.
        Manufacturing requirements This product should be extracted from healthy human urine. The production process should conform with the requirements of current version of Good Manufacturing Practice. This product should have virus safety control measures in the production process, and the process needs to be heated at 60℃?for 10 hours to inactivate the virus.
        Pharmacopoeia standard

        CP

        EP/BP

        JP

        Character

        White or almost white, amorphous powder. white or almost white, amorphous powder.?Solube in water Urokinase is a clear and colorless liquid. The pH is between 5.5 and 7.5.

        Identification

        Coagulate within 30~45 seconds, and the clot should re-dissolve within 15 minutes. In both tubes, a clot forms and lyses within 30 min. Lysis circle appears.
        The clot is insoluble within 2 hours Carry out identifification by a suitable immunodiffusion test. Stand for overnight: a clear precipitin line appears.

        Tests

        Appearance of solution The solution is clear and colorless The solution is clear and colorless Clear and colorless liquid
        Hepatitis B surface antigen Negative(10mg/ml) Negative _________
        Purity (1)Heavy metals _________ _________ Not more than 10ppm
        (2)Blood group substances _________ _________ The agglutination is equal in both lanes.
        Loss on drying ≤5.0% (dry at 60°C under reduced pressure to constant weight) _________ _________
        Thromboplastic contaminants Not less than 150 IU/mL. Not less than 150 IU/mL. _________
        Molecular fractions. _________ Not less than 2.0 _________
        High-molecular mass Urokinase (SDS-PAGE) Not less than 90% _________ _________
        High-molecular mass Urokinase (HPLC) Not less than?85 % _________ Not less than 0.85
        Total protein _________ Conform with regulations _________
        Abnormal toxicity Conform with?regulations(5 000 IU/ml) _________ Conform with regulations
        Pyrogens _________ Equivalent to 20 000 IU/mL. _________
        Bacterial Endotoxin ≤1.0 EU/10000?units _________ _________

        Potency

        Assay _________ _________ Not less than 60000IU/mL
        Specific activity Not less than 120000IU/mg.pr Not less than 70000IU/mg.pr Not less than 120000IU/mg.pr

        Microbial limit

        TAMC ≤103CFU/g ≤103CFU/g ≤103CFU/g
        TYMC ≤102CFU/g ≤102CFU/g ≤102CFU/g
        Escherichia coli Should not be detected(10mg/ml) Should not be detected Should not be detected

        Virus

        Hbs Ag Should be negative(10mg/ml) Should be negative Should be negative
        HCV antibodies _________ Should be negative Should be negative
        HIV I+II _________ Should be negative Should be negative

        Storage

        Store in an airtight container, protected from light, at a temperature not exceeding 10°C. Store in an airtight container, protected from light, at a temperature not exceeding 8 °C. Containers—Tight containers.Storage—Not exceeding -20°C.

        Preparation

        Urokinase for injection

        Category

        Thrombolytic drugs

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