Contaminants Leached from Rubber Stoppers into a Water Soluble Vitamin E Intravenous Injectable Product

Pesticides

“…An injectable, water-soluble vitamin E product was examined for contaminants from rubber stoppers by using gas chromatography, gas chromatography/mass spectrometry, high-performance liquid chromatography, and inductively coupled plasma emission spectroscopy (76). Dibutylamine, dimethylcyclohexylamine, mercaptobenzothiazole, and zinc contaminants were observed.…”

Development and validation of HPLC methods for the determination of potential extractables from elastomeric stoppers in the presence of a complex surfactant vehicle used in the preparation of parenteral drug products

“…Regulatory bodies in Europe and Japan have similar requirements for container/closure systems. Various reports in the literature have, however, shown measurable amounts of these stopper ingredients in parenteral solutions [9][10][11][12][13].…”