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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 : 22/08/2015

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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