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Technical Articles > Aluminum
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Aluminum (Al) is of concern in dialysis fluids and
in some drugs for injection (parenterals). While blood levels are
normally 0-2 ug/L, dialysis patients have elevated levels of aluminum, >20
ug/L. Early links of aluminum to Alzheimer's disease are currently thought
to be unimportant.
FDA RegulationsFDA has established a 25 ug/L limit for aluminum in products used in total parenteral nutrition (TPN) therapy. This applies to manufacturers of large volume parenterals (LVPs), small volume parenterals (SVPs), and pharmacy bulk packages (PBPs) used for TPN therapy.[21 CFR 201.323] For a review of biological speciation and toxicity, click here. |
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