Resumen de Stability and compatibility of Hidrofundin Fisiologico® with calcium and magnesium salts
M.J. Esteban Mensua, C. Borrell García, M. Galiana Sastre, Eduardo López Briz, José Luis Poveda Andrés
Objective: To assess stability of Hidrofundin Fisiologico® when several concentrations of magnesium and calcium salts were added. Method: Magnesium as sulphate (3.05, 6.1 and 9.15 mmol Mg+2) was added to a 500 ml of Hidrofundin Fisiologico®. Another 500 ml sample was added with 3.05 mmol magnesium and 2.3 mmol calcium. All assays were carried out in aseptic conditions and at a room temperature. Samples were assessed for pH, ion determination, polarimetry and particle size determination at 0, 12,24,48 and 72 hours. Results: Data suggest that stability parameters don't alter along the time of study. Discoloration, appearance, opalescence, pH, calcium, magnesium, sodium, chloride and mannitol concentrations as well as subvisible particulate matter were not modified along the study, allowing us to use Hidrofundin Fisiologico® admixtures described within 72 h. Conclusion: Hidrofundin Fisiologico® is physically and chemically stable when mixed with calcium and magnesium salts at least for 72 h at room temperature
