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rhug-csf_75µg   GENTAUR HEADQUARTERS  +32 1641 4407  +32 1650 9045 

 rHuIL-2-3MIU huIFNa-2a huIFNa-2b Mouse GM-CSF rHuIL-4 GMPhuIL-4-50µg RHUGMCSF-300µg RHUGM-CSF-50µg huG-CSF-300µg huIL-6 -50 µg rhug-csf 300µg rhug-csf_75µg rhuil-1b-100µg

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rHuG-CSF 75µg

75 µg :Quantity

rHuG-CSF-75  : Code

200802B06  : Batch

 2010/02/15 : Exp.Date

2 – 8°C : Storage

 

CERTIFICATE OF ANALYSIS

Tests

Specifications

Results

Identification (Immunoblot)

Positive

Positive

Appearance

Clear, colorless solution

Complies

Particulate Matter

 

 

         Visible particles

Free of Visible foreign particles

Complies

         Sub-visible particles

≥10µm: ≤6000/vial

≥25µm: ≤600/vial

 

848

34

 

Mass Variation

Complies to EP 5th

Complies

pH

3.50 – 4.50

4.23

Potency

80% - 150% of stated value

(4.80 –9.000 x 106IU/vial)

127%

(7.62 x 106IU/vial)

Sterility

Sterile

Sterile

Abnormal Toxicity test

Complies to EP 5th

Complies

Pyrogen Test (Rabbit)

Complies to EP 5th

Complies

Bacterial Endotoxins

Not more than 0.25EU/ml

Less than 0.25EU/ml

Conclusion

Complies

Complies

  

 

 

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Last modified: 06/25/09