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尿激酶|UK-150407-07

2017-05-23 16:34:13 万华生化制品 阅读

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

 

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