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Validated ICPMS Methods

We have validated test methods for aluminum.  We test for aluminum in a variety of biological, pharmaceutical, and environmental samples using ICPMS. Detection limits are usually in the 1-10 ug/L range depending on the sample type.  

For a quotation...

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 Regulations

FDA 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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