Approximately eighty-five samples of injectable biological products regulated by the Center for Biologics Evaluation and Research were surveyed for the presence of eleven elements, namely, aluminum arsenic, barium, cadmium, chromium, lead, mercury, selenium, thallium, and zinc by flame and flameless methods of atomic absorption spectroscopy and flame emission spectroscopy. The majority of the metal concentrations in these products were low or undetectable. The metal levels varied from manufacturer to manufacturer, product to product and lot to lot of the same manufacturer's products. House dust allergenic extract had the highest concentration of arsenic (2.4 ppm), cadmium (0.28 ppm), chromium (0.6 ppm) and lead (1.5 ppm) found in the study. A high zinc concentration (24 ppm) in an immune serum globulin was attributed to the zinc-containing rubber stopper in contact with product. A range of 0.36 to 3.3 ppm albumin was found for seven 25% serum albumin samples from seven manufacturers. Values of 8.2, 17, and 18 ppm albumin were found in one manufacturer's 25% serum albumin. These albumin values appeared to be the result of an anomaly in this manufacturer's production that has not been repeated to date. Thirty-six samples of source plasma and several samples of anticoagulant and saline associated with source plasma will be analyzed for their aluminum content by electrothermal atomization atomic absorption spectrometry. Source plasma is the starting material for the production of serum albumin. The level of albumin found in source plasma will indicate the level of aluminum that serum albumin can not be expected to have less than. A reference material prepared at CBER was assayed for aluminum by two analytical techniques at the National Bureau of Standards.
