Influence of the glass packing on the contamination of pharmaceutical products by aluminum. Part I: Salts, glucose, heparin and albumin

Abstract

The presence of aluminium (Al) in pharmaceutical products used parenterally as sodium and potassium chlorides, glucose, heparin and albumin were investigated with respect to their storage in glass containers. As glasses can have aluminium in their composition, the aluminium may be released from the glass into the solution. The action of the substances above mentioned were investigated storing their solutions in glass and plastic containers, and measuring the aluminium in solution at determined time intervals. The aluminium present in the commercial pharmaceutical products, stored in both plastic and glass containers were also measured. All glass containers were analysed to determine their aluminium content. The aluminium determinations were done by atomic absorption spectrometry. The results showed that aluminium is present in all analysed glasses in a percentage of 0.6 to 3%. Although all substances already have a residual aluminium contamination, the major contribution comes from the glass containers in which their solutions were stored. The contamination arising from glass depends too much on the nature of the substance. While the salts extracted about 400 μg Al/l in 60 days, glucose extracted 150 μg Al/l, and albumin and heparin about 500 μg Al/l in the same time interval. Commercial solutions of glucose contain about 10 μg Al/l when stored in polyethylene and from 350 to 1000 μg Al/l when in glass ampules. Considering all commercial products, solutions stored in plastic containers contained no more than 20 μg Al/l whereas in glass the aluminium contamination reached 1000 μg/l, and in all of them the aluminium increases with the age of the product.