title: Gas chromatographic-mass spectrometric analysis and subsequent quality improvement of plastic infusion packaging materials.
abstract: Although the opalescence of sterile transparent plastic materials utilized for the packaging of parenteral infusion drugs is a serious quality problem, most suppliers do not report the exact compositions of such polymers, and no literature data are available. Similarly, no information is available as concerns the potential incompatibility of the inner bag and the overpouch. Our gas chromatographic-mass spectrometric study revealed that the cause of the opalescence is the presence of a low-molecular-weight slip additive, 13-docosenamide (erucamide), which is transferred into the primary infusion bag from the overpouch during the heat-sterilization process. Autoclaving trials confirmed the analytical results. In view of these findings, a new slip additive-free overpouch has been produced as secondary packaging material, which does not give rise to opalescence.
authors.affiliation: Analytical Development Department, Generic Research & Development, TEVA Pharmaceutical Works PLC, Táncsics Mihály u. 82, H-2100 Gödöllő, Hungary. Electronic address: zfekete001@gmail.com.
authors.forename: Z
authors.initials: Z
authors.lastname: Fekete
authors.affiliation: Chemical Control Department, Quality Control Division, TEVA Pharmaceutical Works PLC, Táncsics Mihály u. 82, H-2100 Gödöllő, Hungary.
authors.forename: T
authors.initials: T
authors.lastname: Rófusz
authors.affiliation: Analytical Development Department, Generic Research & Development, TEVA Pharmaceutical Works PLC, Táncsics Mihály u. 82, H-2100 Gödöllő, Hungary.
authors.forename: V
authors.initials: V
authors.lastname: Angyal
authors.affiliation: Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Szeged, Eötvös u. 6, H-6720 Szeged, Hungary.
authors.forename: P
authors.initials: P
authors.lastname: Szabó-Révész
authors.affiliation: Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Szeged, Eötvös u. 6, H-6720 Szeged, Hungary.
authors.forename: Z
authors.initials: Z
authors.lastname: Aigner
mesh_terms: D004344:Drug Incompatibility; D004349:Drug Packaging; D004883:Erucic Acids / Q000032:analysis*; D008401:Gas Chromatography-Mass Spectrometry; D010969:Plastics / Q000737:chemistry*; D011108:Polymers / Q000737:chemistry; D058996:Quality Improvement; D013242:Sterilization
chemical_list: D004883:Erucic Acids; D010969:Plastics; D011108:Polymers; C049508:erucyl amide
keywords: GC–MS; Opalescence; Packaging material; Polymer foil; Quality