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Precautions when checking Urokinase manufacturer products

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  Notes for urokinase product inspection are as follows:

       1.For the clarity and color of the solution, take this product and add 0.9% sodium chloride solution to make A solution containing 3000 units per 1 ml, and check it according to law (Appendix IX A and B of Part II of pharmacopoeia 2010 edition). It should be clear and colorless.

Precautions when checking Urokinase manufacturer products

  2. Molecular component ratio: take the product, dissolve it in water and make a solution containing 2mg per 1ml, then add the same volume of buffer solution (2.5ml of concentrated glue buffer, 2.5ml of 20% sodium dodecyl sulfate solution, 1.0ml of 0.1% bromophenol blue solution and 3.5ml of 87% glycerol solution, add water to 10ml), and put it in water bath for 3 minutes. Cooling, as the test solution; Take the test solution 10μ L, add it to the sample well, and determine by electrophoresis (Coomachus blue staining, Method 5, Appendix ⅴ, Part II, Pharmacopoeia 2010 edition), calculate the relative content of high molecular weight urokinase (%) as follows:

  3. Dry weightlessness, take this product, phosphorus pentoxide as desiccant, vacuum drying at 60℃ to constant weight, weight loss should not be more than 5.0% (Appendix ⅷ L, Part II, 2010 edition of Pharmacopoeial).

  4. Hepatitis B surface antigen, take this product, add 0.9% sodium chloride solution to make a solution containing 10mg per 1ml, according to the kit instruction, should be negative.

  5. Abnormal toxicity, take this product, add sodium chloride injection to make a solution containing 5000 units per 1ml, check according to law (2010 edition Of Pharmacopoeia Part II Appendix C), administer it by intravenous injection, which should meet the requirements.

  6. Bacterial endotoxin, take this product and inspect according to law (2010 Version Of Pharmacopoeia Part II Appendix E). The amount of endotoxin in urokinase per 10,000 units should be less than 1.0EU.

  7. Coagulant like active substances.

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