Particulte matter in biocarbonate Ringer's solution

A bicarbonate Ringer's injection containing both HCO₃ ^- and Ca²⁺ may precipitate calcium carbonate during the clinical use while this has not been evaluated. The present study was designed to examine how many obscuration particles exist in bicarbonate Ringer's solution upon the simulated clinical use. Soft containers of 500 ml bicarbonate Ringer's injection BICANATE^TM and saline injection maintained at 5, 23 or 40°C for 20 hrs were evaluated. After one hour infusion at 450 ml/hr, the number of particles equal to or greater than 25 μm, which existed in one ml of saline injection at 40°C, BICANATE^TM injection at 23°C or 40°C was significantly less than that in saline injection at 23°C. However, the number equal to or greater than 10 μm did not differ among groups tested. Different infusion speed from 125 to 450 ml/hr did not alter the number of particles in BICANATE^TM injection at 23°C. All data regarding the number of particles obtained in this study satisfied the limitation advised by the United States, European and Japanese Pharmacopeia. The current study suggests the possible use of bicarbonate Ringer's injection in a clinical condition.