Determination of Al in selected parenteral albumin products by ICP-MS

Intravenous administration increases the potential exposure to Al because it bypasses the body’s normal barrier systems. Upper limit of 200 ppb of Al for parenteral products is set by manufacturer’s analytical procedures. Inductively coupled plasma mass spectrometry is a method of choice for it is sensitive, accurate and precise enough. It would be beneficial if sample preparation steps would be simplified and without possibility of cross contamination with Al. Parenteral albumin products were diluted appropriately with solution containing: NH3, Triton 100 and EDTA prepared in UHQ water. The same solution was used for preparation of Al standard solutions. As an internal standard 1 ppb Ge, m/z 74, was used. Measurements were made in No Gas, He and H2 mode using ICP-MS QQQ. It was found that No Gas mode was suitable for Al determination. Recovery, reproducibility, LOD and LOQ were satisfactory which were a proof of acceptability of the proposed method. It was determined that all of tested parenteral products had Al bellow the limit.