Contribution of the raw material to the aluminum contamination in parenterals

Abstract

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. METHODS: The measurements were done by atomic absorption spectrometry. RESULTS: The results showed that the same product might have different aluminum content depending on the manufacturer, either for commercial formulations or substances. The highest contaminated chemicals included cystine, NaOH, vitamin C, biotin, gluconate, and Fe and Cr salts. The lowest contaminated chemicals included lipids, apolar amino acids, glucose, HCI, acetic acid, KCl, NaCl, and heparin. Among commercial products, the major contamination rates appeared in calcium gluconate, followed by trace elements, some vitamins, bicarbonate, phosphates salts, and heparin. CONCLUSIONS: Comparing the aluminum in commercial products and substances, it can be concluded that the contamination may occur in parenterals because aluminum is present naturally in the chemicals. However, when the composition and concentration of the parenteral solution are considered, the contamination of calcium gluconate, trace elements, some vitamins, phosphates, bicarbonate, and heparin cannot be related only to the raw substances. The aluminum level present in these commercial formulations is too high to come only from the substances; therefore, it is possible that one of the steps of the manufacturing procedure is responsible for elevating the contamination of these products.

Aluminum was measured in commercial parenteral formulations (35 different products, 276 samples) and in the correspondent raw substances (68 products, 250 samples). Raw material contributes to the contamination of the formulation however, some commercial products show an aluminum content that is too high to be caused by the raw substance alone.