A survey of the concentrations of eleven metals in vaccines, allergenic extracts, toxoids, blood, blood derivatives and other biological products.
Approximately 85 samples of injectable biological products regulated by the Center for Drugs and Biologics of the United States Food and Drug Administration were surveyed for the presence of 11 elements, namely aluminum, arsenic, barium, cadmium, chromium, lead, mercury, selenium, thallium and zinc, by flame and flameless methods of atomic absorption spectrometry and flame emission spectrometry. The range of products tested included whole blood, red cells, plasma, normal serum albumin, antihemophilic factor, and other products derived from blood; allergenic extracts including honey bee venom and house dust allergenic extracts; vaccines such as measles virus vaccine and typhoid vaccine; and tetanus toxoid. The metal concentrations found in the majority of these products were low or undetectable. The metal levels varied from manufacturer to manufacturer, product and lot-to-lot of the same manufacturer's products. House dust allergenic extracts had the highest concentrations 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 the product. A range of 0.36-3.30 ppm aluminum was found for seven 25% normal serum albumin samples from seven manufacturers. Values of 8.2, 17 and 18 ppm aluminum were found in one manufacturer's 25% normal serum albumin. These aluminum values appeared to be the result of an anomaly in this manufacturer's production that has not been repeated to date.
D000485:Allergens / Q000032:analysis*; D001688:Biological Products / Q000032:analysis*; D001798:Blood Proteins / Q000032:analysis / Q000627:therapeutic use; D006801:Humans; D007106:Immune Sera / Q000032:analysis; D008670:Metals / Q000032:analysis / Q000097:blood; D013054:Spectrophotometry, Atomic / Q000379:methods; D014121:Toxoids / Q000032:analysis*; D014612:Vaccines / Q000032:analysis*
D000485:Allergens; D001688:Biological Products; D001798:Blood Proteins; D007106:Immune Sera; D008670:Metals; D014121:Toxoids; D014612:Vaccines