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An experimental study of residual chemicals in elastomeric stoppers for injectables: a MS/GC survey and a headspace/GC purity test

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Summary

Elastomeric stoppers for injectables have been surveyed by means of GC/MS screening. Residual contamination by hexanes (2-methylpentane, 3-methylpentane, n-hexane, methylcyclopentane, cyclohexane) toluene and xylenes occurred in all the samples tested.

A headspace GC purity test is suggested, by using these residual chemicals as purity indexes.

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References

  1. Farmacopea Ufficiale Repubblica Italiana, IX Ed. (Italian Republic Official Pharmacopoeia, 9th Ed.) Istituto Poligrafico e Zecca dello Stato, Roma, 1985; Vol. 1, p. 442.

  2. European Pharmacopoeia, Council of Europe; Draft Monograph “Rubber closures for containers for aqueous preparations for parenteral use” Strasbourg, 1981.

  3. Hewlett Packard Application Brief, AB85-13, Publ.n. 23-5953-8059 (1985).

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Authors and Affiliations

  1. Lab. Tossicologia Applicata, Istituto Superiore di Sanità, V. Regina Elena, 299, 00161, Roma, Italy

    L. Gramiccioni, M. R. Milana, A. Maggio, R. Feliciani & C. Gesumundo

Authors
  1. L. Gramiccioni
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  2. M. R. Milana
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  3. A. Maggio
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  4. R. Feliciani
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  5. C. Gesumundo
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Gramiccioni, L., Milana, M.R., Maggio, A. et al. An experimental study of residual chemicals in elastomeric stoppers for injectables: a MS/GC survey and a headspace/GC purity test. Chromatographia 28, 545–550 (1989). https://doi.org/10.1007/BF02260674

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  • DOI: https://doi.org/10.1007/BF02260674

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