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RHUGMCSF-300µg   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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 ANALYSIS DATA SHEET

PRODUCT: MOLGRAMOSTIM, mGMP rHu GM-CSF, 300µg (2 800 000 UNI) / 385 Euro

Activity: 10 000 000 UNI /mg

Expiry date : 22/08/2005

BATCH NUMBER 30029/P35369/P11712/1

Essay

SPECIFICATION/LIMITS

RESULTS

 

DESCRIPTION

White powder, Lyophilized, homogeneous

Accomplished

 

PH 20§C reconstitute

7.00 8.00 (electrometric Met)

 

7.40

 

 

Reconstitute avec solvent

Colourless, clear liquid, free of particles in suspension Accomplished

 

Medium weight

53.0 66.0 mg/vial

54.9mg/vial of 300ug

 

Water -Karl Fisher-

NO > 3%

2.1%

 

Bacteria’s Endotoxines

NO > 25 EU/vial

< 5 EU/vial

 

Sterilisation

Must fulfil essay

Accomplished

 

Innocuous

Must not induce dying or loss of weight for the animal injected Accomplished

 

Limits of DNA contaminated

DNA Content E. Coli = or < 100.0 pg/vial Accomplished

 

Western Blot

Must present a (Band) that correspond to the position (band) of reference Accomplished

 

Electrophoresis

Molecular weight : 13.500 15.500 Daltons

14.999 D

 

MOLGRAMOSTIM

The estimated potential must be between 7.00 130.0 of declared potential ( 3.00 MUI/vial) 2.80 MUI/vial

93.3 %

 

Obs: (a) P = 95%(2.66-2.95 MUI/vial) * P-GEN SA/

Analysed by : ROMINA ROZENCWAIG / DR. SERGIO PALOTTO / LIEVEN GEVAERT

on 22/07/2004

 

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