Aluminum content of source plasma and sodium citrate anticoagulant.
The concentration of aluminum was determined in samples of source plasma collected by the normal plasmapheresis procedure, which involves collection in anticoagulant and immediate freezing. Samples of sodium citrate anticoagulant used in the collection of source plasma were also tested for aluminum, as were empty source plasma containers and 0.9% sodium chloride infusion (USP). Samples of source plasma were collected from a geographic cross-section of the donor population in the USA by three different manufacturers. Aliquots of these samples were mixed with Triton X-100 and sulfuric acid and analyzed for aluminum by atomic absorption spectrometry using electrothermal atomization (graphite furnace) and Zeeman background correction. The arithmetic mean and standard deviation for the aluminum content of 28 samples of source plasma were found to be 25.5 +/- 8.4 ng Al/ml. The aluminum content of the individual samples of source plasma ranged from 12 to 48 ng Al/ml. The aluminum content of 6 samples from two manufacturers of the sodium citrate anticoagulant that is used in source plasma ranged from 410 to 2,080 ng/ml. Aluminum levels found in saline for infusion and nitric acid leachates from empty source plasma containers were less than 6.9 ng/ml. The level of aluminum expected in uncontaminated human blood has been estimated to be 10 ng Al/ml or less. Comparison of this figure with the present data indicates that the sodium citrate anticoagulant contributes significantly to the aluminum load of source plasma and, therefore, to the aluminum content of products such as albumin derived from source plasma.
May
J C
JC
Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Md.
Rains
T C
TC
Yu
L J
LJ
Etz
N M
NM
D000535:Aluminum / Q000032:analysis* / Q000097:blood; D000925:Anticoagulants / Q000737:chemistry*; D001782:Blood Donors; D001800:Blood Specimen Collection / Q000295:instrumentation*; D002951:Citrates; D019343:Citric Acid; D006801:Humans; D010956:Plasmapheresis / Q000295:instrumentation*; D010969:Plastics / Q000737:chemistry; D012965:Sodium Chloride; D012996:Solutions / Q000737:chemistry*; D013054:Spectrophotometry, Atomic; D014481:United States
D000925:Anticoagulants; D002951:Citrates; D010969:Plastics; D012996:Solutions; D019343:Citric Acid; D012965:Sodium Chloride; D000535:Aluminum