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Tuesday, 21 May 2013 15:35

mGMP GM-CSF, 50ug batch20040823

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Product number 04-RHUGM-CSF-50UG
Product name mGMP GM-CSF, 50ug batch20040823
Quantity  
Supplier

GENTAUR

 

 

Test

Specifications

Results

Identification

Positive

Positive

Appearance

Looks like a white to off-white crisp cake. After reconstitution, the solution is clear, colorless

Complies

Particulate Matter

 

 

           Visible particles

Free of visible foreign particles

Complies

 

           Sub-visible particles

= 10µm: = 6000/vial

= 25µm: = 600/vial

393

21

Weight of content

90% - 110% of he stated value

Complies

PH

6.50 – 7.50

7.22

Moisture

= 3.0%

0.6%

Potency

80% - 150%

( 4.40-8.25x105IU/vial)

114%

(6.25x105IU/vial)

 

Sterility

Sterile

Sterile

Abnormal Toxicity Test

Complies to EP 5th /CP 2005

Complies

Pyrogen Test (Rabbit)

Complies to EP 5th

Complies

Bacterial Endotoxins

Not more than 0.25 EU/vial

Less than 0.25 EU/vial

Conclusion

Complies

Complies

 

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