Chitosan is a natural product having wide range of applications in the
food and cosmetic industries. Food and commodity grade chitosan are laden
with pyrogens, such as endotoxins and proteins which limit its
applicability in the biological and medical arenas, as minute amounts of
endotoxins may induce adaptive and innate responses when contacted with
mammalian tissue, pharmaceuticals and biomedical devices. Due to
chitosan's ability to avidly bind endotoxin and other pyrogens, they are
difficult to remove. The present invention is directed to methods for
purifying chitosan from shells, food and commodity grade chitosan into
ultra-pure, low endotoxin chitosan having biological and medical
applicability. Additionally, the present invention is also directed to a
method of determining the pyrogenicity of the ultra-pure low endotoxin
chitosan.