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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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