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      Endotoxin Level of Sterile Injection Solutions and Substitution Fluid for Hemofiltration in Japan and Australia

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          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)·ml<sup>-1</sup>. Only 2 solutions in 30 from both countries showed higher levels: 7.7 and 10.8 pg for E. coli 0111 :B4 endotoxin ml<sup>-1</sup> (0.02 and 0.03 EU · ml<sup>-1</sup>). 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 · ml<sup>-1</sup> (0.024–0.027 EU · ml<sup>-1</sup>).

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          Author and article information

          S. Karger AG
          04 December 2008
          : 42
          : 2
          : 128-132
          aWater Research Institute, Nagoya University, Nagoya; bTokyo Research Institute, Seikagaku Kogyo Ltd., Tokyo; cInstitute of Environmental Science for Human Life, Ochanomizu University, Tokyo, Japan
          183651 Nephron 1986;42:128–132
          © 1986 S. Karger AG, Basel

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          Pages: 5
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