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

Research paper by L. Gramiccioni, M. R. Milana, A. Maggio, R. Feliciani, C. Gesumundo

Indexed on: 01 Dec '89Published on: 01 Dec '89Published in: Chromatographia


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.