title: Endotoxin level of sterile injection solutions and substitution fluid for hemofiltration in Japan and Australia.
abstract: The endotoxin contamination levels of sterile distilled water and saline solutions used for injection and hemofiltration in Japan and Australia were examined with a colorimetric limulus test using a chromogenic substrate. The endotoxin levels of injection solutions in most products from both countries measured against E. coli 0111:B4 endotoxin or USP reference standard endotoxin were less than 0.2 pg or 0.0006 endotoxin units (EU) X ml-1. Only 2 solutions in 30 from both countries showed higher levels: 7.7 and 10.8 pg for E. coli 0111:B4 endotoxin X ml-1 (0.02 and 0.03 EU X ml-1). Even these higher values were well below the level recommended by the draft guideline published by the United States Food and Drug Administration (FDA). The endotoxin contamination level of a Japanese hemofiltration substitution fluid ranged from 8.2 to 9.2 pg E. coli 0111:B4 endotoxin X ml-1 (0.024-0.027 EU X ml-1).
mesh_terms: D001315:Australia; D003124:Colorimetry / Q000379:methods; D004731:Endotoxins / Q000032:analysis*; D004926:Escherichia coli; D006801:Humans; D007564:Japan; D008033:Limulus Test; D011786:Quality Control; D006435:Renal Dialysis; D012965:Sodium Chloride; D012996:Solutions; D014867:Water
chemical_list: D004731:Endotoxins; D012996:Solutions; D014867:Water; D012965:Sodium Chloride; C044101:endotoxin, Escherichia coli