Test Report on lyophilized FGF
(Recombinant Human Acidic Fibroblast Growth Factor)

Sample name lyophilized aFGF Package of the sample Penicillin bottle
Batch no. FGF-080320 Sample specification 2mg / bottle
Producing unit Preparation packaging workshop Shelf life (under 4-8°C) 3 years
Consigner Preparation packaging workshop Representative amount 1720
Test purpose Detection of lyophilized FGF Samples 20
Test items All components Assay date March. 20th, 2008
Test basis Codex of Chinese, 2005, NO3. Report date March. 22th, 2008

Test items Standard Test result
Purity by HPLC 95% min 98.4%
Activity unit 1.0?05IU/mg min 1.2?05IU/mg
Appearance It is white and aerosols. Added into 1ml distilled water, it can solve quickly.
It should not contain insoluble matter seen by naked eyes. It is white and aerosols. Added into 1ml distilled water, it can solve quickly.
It does not contain insoluble matter seen by naked eyes.
pH value 6.0 - 6.6 6.2
Water residue ≤1.0% 0.6%
Abnormal toxicity exp. The tested animals have No abnormal
reactions. They keep healthy, and have weight increase. The tested animals have No abnormal reactions. They keep healthy, and have weight increase.
Sterility test No bacterial growth No bacterial growth
Conclusion: This batch of lyophilized FGF conforms to requirements of the quality standard.