Investigation of drug product and container-closure interactions: A case study of diluent containing prefilled syringe

Thakare, Vivek; Mayr, Bettina; Artenjak, Andrej; Nianios, Dimitrios; Sest, Maike; Müller, Martin; Maltsev, Oleg V.; Nowicki, Kajetan; Mischo, André; Ehrenstrasser, Christian; Fink, Matthias; Thanhaeuser, Silvia; Cerreti, Alessandra

doi:10.1016/j.ejpb.2019.04.018

Cited by 5 publications

(1 citation statement)

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“…Trace levels of extractables and leachables in matrices, sometimes relatively complex, is a real challenge for analysts, because the tests need to reach very low limits (ppb levels) of detection and/or quantification. Therefore, gas chromatography-mass spectrometry (GC-MS) is often used in CCI studies, for its sensitivity, in food [ 6 , 11 , 12 , 13 , 14 , 15 ], pharmaceutical [ 16 , 17 , 18 , 19 ], medical [ 20 , 21 ], and cosmetic [ 7 , 22 , 23 , 24 , 25 ] studies. Liquid chromatography is also used, whether it is with a UV, fluorescent, [ 17 , 26 , 27 , 28 ] or mass spectrometer detector [ 28 , 29 , 30 , 31 , 32 ].…”

Section: Introductionmentioning

confidence: 99%

Identification of Potential Extractables and Leachables in Cosmetic Plastic Packaging by Microchambers-Thermal Extraction and Pyrolysis-Gas Chromatography-Mass Spectrometry

et al. 2020

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Most container–content interaction studies are carried out through migration tests on end products or simulants involving generally toxic solvents. This study was conducted with the aim of identifying potential leachables from materials used in cosmetic plastic packaging by using two approaches based on solvent-free extraction, i.e., solid-phase microextraction sampling and pyrolyzer/thermal desorption coupled with gas chromatography mass spectrometry. Volatile and semi-volatile intentionally and non-intentionally added substances were detected in seven packaging samples made of polypropylene, polyethylene, and styrene-acrylonitrile copolymer. Thirty-five compounds related to the polymers industry or packaging industry were identified, among them phthalates, alkanes, styrene, and cyanide derivates including degradation products, impurities, additives, plasticizers, and monomers. All except eight belong to the Cramer class I. These thermodesorption techniques are complementary to those used for migration tests.

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