[Evaluation of contamination of serum derived intravenous preparations].
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.
Aleksandrowicz
J
J
Zakład Badania Surowic i Szczepionek Państwowego Zakładu Higieny w Warszawie.
Fiejka
M
M
Słowikowska
M
M
D000418:Albumins; D004340:Drug Contamination; D006801:Humans; D007136:Immunoglobulins; D007262:Infusions, Intravenous; D011044:Poland; D012996:Solutions
D000418:Albumins; D007136:Immunoglobulins; D012996:Solutions