PREPARATION OF AN INTRA-LABORATORY REFERENCE MATERIAL - DETERMINATIONOF THE ALUMINUM CONTENT OF A POOLED 5-PERCENT ALBUMIN (HUMAN) SOLUTION BY ETAAS, MFS AND ICP-AES

Human albumin solutions as well as other biological products intended for human use may contain aluminum as a result of intentional addition due to manufacturing protocol or through inadvertent contamination oc curing during the manufacturing process. Because of the implication of aluminum in human disease, it is desirable that aluminum levels in th ese products be monitored. To satisfy the need for a reference materia l that is representative of albumin products that are intended for the rapeutic use, a pooled 5% human albumin solution was prepared in bulk to serve as a reference for aluminum during analytical procedures. Ali quots of the albumin pool were analyzed for their aluminum content by three independent analytical methods, namely, electrothermal atomic ab sorption, molecular fluorescence and inductively coupled plasma-atomic emission spectrometry. Measured values for aluminum in the albumin so lution showed good agreement between the different analytical methods. The concentration of aluminum was determined to be 0.512 mu g Al/ml b y the atomic absorption method, 0.502 mu g Al/ml by molecular fluoresc ence, and 0.498 mu g Al/ml by the inductively coupled plasma-atomic em ission method. The overall average concentration was calculated to be 0.507 mu g/ml +/- 0.009 mu g Al/ml. The preparation of the albumin ref erence and its subsequent aluminum analysis is described. (C) 1996 The International Association of Biological Standardization