Influence of the glass packing on the contamination of pharmaceutical products by aluminium. Part III: Interaction container-chemicals during the heating for sterilisation.

The interaction of chemicals with the container materials during heating for sterilisation was investigated, storing the components of parenteral nutrition solutions individually in sealed glass ampoules and in contact with a rubber stopper, and heating the system at 121 degrees C for 30 min. Subsequently, the aluminium content of the solutions was measured by atomic absorption spectrometry (AAS). The assay was also carried out with acids, alkalis and some complexing agents for Al.

Contribution of the raw material to the aluminum contamination in parenterals.

Background: The extent of aluminum contamination in parenteral nutrition solutions was measured in 35 different commercial products, including amino acids, electrolytes, glucose, lipids, vitamins trace elements, and albumin. The extent of aluminum contamination in substances used as raw material for preparation of parenterals was also measured. Chemicals from different manufacturers and of different quality grades were analyzed individually.