Endotoxin level of sterile injection solutions and substitution fluid for hemofiltration in Japan and Australia.
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).
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
D004731:Endotoxins; D012996:Solutions; D014867:Water; D012965:Sodium Chloride; C044101:endotoxin, Escherichia coli