Investigation of Endotoxins in Reverse Osmosis Water and Dialysate

OBJECTIVE:To establish the quality control criteria and method for endotoxins in reverse osmosis(RO)water for hemodialysis and dialysate.METHODS:Taking different countries' biological limiting value standards on reverse osmosis(RO)water for hemodialysis and dialysate as reference,we established microbiological culture and kinetic turbidimetry based on the related method stated in China Pharmacopeia(2005 Edition)and monitored and evaluated the specimens.RESULTS:The established criteria for the RO water,the dialysis(withont filtration)and the ultrafiltrate were 100,200,1 cfu·mL-1 for microorganisms and for endotoxins were 0.25,1.0 and 0.10 EU·mL-1,respectively.The assaying results of the specimens in the above criteria were all up to the standard.CONCLUSION:The established method is feasible and it can ensure the medication safety of hemodialysis.