[Evaluation of contamination of serum derived intravenous preparations]

J Aleksandrowicz1, M Fiejka, M Słowikowska

  • 1Zakład Badania Surowic i Szczepionek Państwowego Zakładu Higieny w Warszawie.

The concentration of Al in 4 lots of 5% Albumina and in 14 lots of 5% immunoglobulins were estimated by adsorptive stripping voltammetric method. Mean Al concentrations amounted to 142.6 micrograms/l in 5% Albumina and to 202 micrograms/l in IVIG preparations produced in Poland. Al concentrations in foreign IVIG preparations ranged from 14 to 54 micrograms/l. These data show the need to consider setting an upper limit of microgram Al/l in i.v. drug products produced or registered in Poland.

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