Preparation and Quality Tests of Trace Element Injections for Intravenous Hyperalimentation

Abstract

At Osaka University Hospital, trace element injections for intravenous hyperalimentation (IVH) were prepared and quality tests were conducted on their content uniformity and sterility. The composition of the injections was: IVH-Zn: Zn 20μmal; IVH-M: Zn 20μmol, Mn 40μmol, Cu 5μmol, I 1μmol. The ingredients were filtrated through 0.45μm membrane filter, filled and wet-sterilized at 121° for 20 minutes. The content uniformity was determined by Atomic Absorption Spectrophotometry. The standard contents of the elements in the injections were determined in the range of 90 to 110w/v%. All lots were negative to Sterility Test (J. P. IX).