Urokinase product inspection matters needing attention are detailed as
1.Clarification 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.
Check according to law (2010 edition of Pharmacopoeia Part II Appendix Ⅸ A and
B), it should be clear and colorless.
2. Molecular component ratio: take this product, add water to dissolve it
into a solution containing 2mg per 1ml, then add buffer solution of equal volume
(take concentrated glue buffer solution of 2.5ml, 20% sodium dodecyl sulfate
solution of 2.5ml, 0.1% bromophenol blue solution of 1.0ml and 87% glycerin
solution of 3.5ml, add water to 10ml), and place in a water bath for 3 minutes.
Cooling, as a test solution; Take 10μl of the test solution, add it to the
sample well, and measure by electrophoresis (2010 edition of Pharmacopoeia Part
II Appendix Ⅴ F Fifth Method Coomasi Bright Blue staining). Calculate the
relative content of high molecular weight urokinase (%) according to the
3. Dry weight loss, take this product, phosphorus pentoxide as desiccant,
at 60℃ decompressed dry to constant weight, loss of weight should not be more
than 5.0%(2010 edition of Pharmacopoia II appendix Ⅷ L).
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
instructions, should be negative.
5. Abnormal toxicity, take this product, add sodium chloride injection into
a solution containing 5000 units per 1ml, check according to law (2010 edition
of Pharmacopoeia Part II Appendix Ⅺ C), according to intravenous injection
method, should meet the requirements.
6. Bacterial endotoxin. Take this product and check it according to law
(Appendix Ⅺ E, Part II of Pharmacopoeia, 2010 edition). The amount of endotoxin
in urokinase per 10,000 units should be less than 1.0EU.
7. Blood clotting like active substances.
Urokinase product inspection matters needing attention Xiaobian first
detailed for you to this, thank you for reading, if necessary, welcome to call
at any time.