For the production the heat shock + purification by extansive diafiltration at low pH method is used which gives a more purified product (albumin fraction) than the Cohn process. The process is taking place in a closed system.
Specifications:
Loss on drying:
< 6.0%
Sulfated ashes (USP):
< 3%
Solubility (2% in water):
Soluble
pH (2% in water):
4.8 - 5.2
Fat:
< 1.0%
Nitrogen:
> 14.0 %
Purity (HPLC):
> 98%
Microbiology:
Total bacterial count:
< 1000 /g
Salmonella:
Negative in 25g
E. coli:
Negative in 0.5g
Other properties:
Lyophilized, whitish-beige coarse powder or scales
Shelf life:
3 years
Raw material used for production is of New Zealand origin. According to the World Organisation for Animal Health (OIE),
New Zealand is recognized as being a country with a negligible BSE-risk, according to OIE, Chapter 11.5 Of the Terrestrial Code.