Schroter, Ariane;Peter, Sonja;Mahler, Hanns-Christian;Zerr, Andreas;Danton, Ombeline;Chalus, Pascal;Koulov, Atanas V.;Huwyler, Jorg;Jahn, Michael published 《Identification of an Oxidizing Leachable from a Clinical Syringe Rubber Stopper》. The research results were published in《Journal of Pharmaceutical Sciences (Philadelphia, PA, United States)》 in 2021.Name: 2,5-Dimethyl-2,5-hexanediol The article conveys some information:
Leaching of toxic or reactive chems. from polymeric materials can adversely affect the quality and safety of biopharmaceuticals. It was therefore the aim of the present study to analyze leachables from a disposable clin. administration syringe using a polysorbate-containing surrogate solution and to assess their chem. reactivity. Anal. methods did include (headspace) GC-MS, Fourier-transform-IR spectroscopy, a ferrous oxidation-xylenol orange assay, and NMR anal. In the syringe leachables solution, the carcinogenic 1,1,2,2-tetrachloroethane (TCE) was detected in concentrations above the ICH M7-derived anal. evaluation threshold. TCE was shown to be an oxidation product of dichloromethane used during sample preparation Since TCE was only isolated from incubations with the contained rubber stopper, we hypothesized that a stopper-derived leachable acted as a reactive oxidant promoting this chem. reaction. Subsequently, the leachable was identified to be the polymerization initiator Luperox 101. Combining different anal. approaches led to the structural elucidation of a chem. reactive oxidant, which has the potential to interact and alter drug products. We conclude that chem. reactive compounds, such as the newly identified rubber stopper leachable Luperox 101, may be of concern and therefore should be routinely considered if a prolonged exposure of polymers with drug products can be anticipated. And 2,5-Dimethyl-2,5-hexanediol (cas: 110-03-2) was used in the research process.
2,5-Dimethyl-2,5-hexanediol(cas:110-03-2) on heteropoly acid catalyzed dehydration yields cyclic ethers via stereospecific intramolecular SN2 mechanism. It reacts with nitriles in concentrated sulfuric acid to yield Δ1-pyrrolines.Name: 2,5-Dimethyl-2,5-hexanediol
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