| 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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