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Urokinase|UK-170202-02

2017-05-23 15:56:51 Wanhua Biochem Products Read

CERTIFICATE OF ANALYSIS

                                               

Product

Urokinase

Lot No.

UK-170202-02

Gross Weight

——

Mfg date

2017-02-08

Net Weight

95.33 g

Exp date

2019-02-07

Total activity

10270 MIU

Test date

2017-02-24

 

Test Items

Specifications

Results

Visual appearance

White to light yellow powder

White powder

Identification

Positive

Conforms

PH

4.0-7.5 (1mg/ml)

6.3

Endotoxin

 2 EU/20,000IU Urokinase

Conforms

HIV I+II

Negative (1,000 IU/ml)

Negative

HCV antibodies

Negative (1,000 IU/ml)

Negative

HBs-Ag

Negative (1,000 IU/ml)

Negative

HIV (PCR)

Negative (10,000 IU)

Negative

HCV (PCR)

Negative (10,000 IU)

Negative

HBs (PCR)

Negative (10,000 IU)

Negative

Molecular fractions

N.L.T 85 % of the urokinase (M.W. 54000)

86.5%

Potency

 75,000 IU/mg

107731.6 IU/mg

Specific activity

N.L.T 100,000 IU/mg.pr

160793.4 IU/mg.pr

Conclusion

Conformly to consult specification

 

Analyst


Checker


Supervisor of QA


 



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