Erucic amide and oleic amide contamination of bicarbonate sodium powder.

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  • 重曹粉末への混入物，エルカ酸アミドおよびオレイン酸アミドについて

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It was found that the erucic amide and oleic amide (both amides, hereafter), used as additives for the antiblock agent in polyethylene bags of bicarbonate sodium powder, can contaminate the dialysate.<br>We have investigated the stages of this process of dialysate contamination and its influence on the human body. We discovered this contamination through a drop in the indicator reading of stock tank conductance with time, about three months after operating the automatic dissolving machine for bicarbonate sodium powder.<br>We recognized oily deposits around various parts of the stock tanks during overhauling of the automatic dissolving machine. The cause of the drop in the indicator reading was the presence of oily deposits on its electrode.<br>After analysis by infrared spectroscopy, we identified the oily deposits as erucic amide. Moreover, after extracting polyethylene bags and bicarbonate sodium powder with ethanol, and after analyzing the materials obtained by gas chromatography and mass spectrometry, we were able to identify the materials as a mixture of erucic amide and oleic amide. It was found that both amides, present in the bags, diffuse into the bicarbonate sodium powder during its storage and thereby contaminate the dialysate during the process of dissolving the powder. The measured amount of both amides mixed into the bicarbonate sodium powder was 0.4ppm. The erucic amide and oleic amide molecules weigh 338 and 281 daltons, respectively, raising the possibility of mixture into the blood through the dialysis membrane during dialysis treatment. No reports have been published, to date concerning the relevant safety and toxicity data on the human body.<br>Accordingly, the necessity of further study on the amounts of both amides mixed into blood, and their influences on the human body over long durations, are needed. Meanwhile, it is strongly suggested that the safety of other hemodialysis materials be reconsidered in light of the process of both amides mixing into bicarbonate sodium powder and then potentially diffusing into the dialysate.

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