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Genprice

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mGMP GM-CSF, 300µg

Catalog #: 04-RHUGM-CSF-300 µg

Price: 385€

 

Technical File
Molgramostim 300µg/vial

(Recombinant Human Granulocyte
Macrophage Colony Stimulating Factor
for Injection)

 

Presentation                      :Box with 1 vial                                                                

Certificate No                    :E2005GM-12                                                        Batch No                           : 20060522

Reference                          :Curretn Pharmacopoea req. fot rHuGM-CSF              Expire date                         :2009/05/22

Molgramostim (Recombinant Human Granulocyte Macrophage Colony Stimulating Factor for Injection) stimulate the production and release of white blood cells (neutrophils) from bone marrow. Neutrophils play a central role in the body’s immune system.

 

TEST

SPECIFICATIONS

RESULTS

Identification

 

Appearance

 

 

After Reconstitution

 

 

 

Particulate Matter

 

pH

 

Moisture

 

Potency

 

 

Sterility

 

Abnormal Toxicity Test

 

Pyrogen test (rabbit)

 

Residual Antibotic Activity

 

Bacterial Endotoxins

 

Positive

 

White cake essentially free
from visible particles

 

Clear, colorless solutions, free from visible particulate matter

 

Complies to current EP

 

6,5 - 7,5

 

≤ 3,0 %

 

80 % - 150 %
(2,64 – 4,95.106 IU/vial)

 

Sterile

 

Complies

 

Negative

 

Negative

 

Not more than 0,25 EU/vial

Positive

 

Complies

 

 

Complies

 

 

 

Complies

 

7,2

 

1,1 %

 

118 %
(3,88.106 IU/vial)

 

Sterile

 

Complies

 

Negative

 

Negative

 

Complies

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Last modified: 05/29/09