title: Analysis of biopharmaceutical market-appropriate plastic syringe barrel for extractables.
abstract: A study was designed to evaluate a new syringe system developed specifically for sensitive pharmaceutical and biopharmaceutical drug products. An in-depth review of the extractables portion of this program is presented and includes data generated by liquid chromatography-mass spectroscopy, gas chromatography-mass spectroscopy, ion chromatography, and inductively coupled plasma of the Crystal Zenith barrel before and after sterilization. One leachable was identified after e-beam irradiation processing. This leachable, identified as an organic acid species, was then evaluated from a safety assessment viewpoint. The details of this program and associated results are explained in this report.
authors.affiliation: West Pharmaceutical Services, 101 Gordon Drive, Lionville, PA 19341, USA. fran.degrazio@westpharma.com
authors.forename: Frances
authors.initials: F
authors.lastname: DeGrazio
authors.forename: Joseph
authors.initials: J
authors.lastname: Runkle
authors.forename: Jeff
authors.initials: J
authors.lastname: Smythe
authors.forename: Amy
authors.initials: A
authors.lastname: Miller
mesh_terms: D001688:Biological Products / Q000032:analysis / Q000592:standards; D002623:Chemistry Techniques, Analytical / Q000379:methods; D003516:Cycloparaffins / Q000032:analysis* / Q000737:chemistry; D004340:Drug Contamination / Q000517:prevention & control; D004349:Drug Packaging / Q000592:standards; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000592:standards; D011108:Polymers / Q000032:analysis / Q000737:chemistry; D013242:Sterilization / Q000379:methods; D013594:Syringes / Q000592:standards*; D013678:Technology, Pharmaceutical / Q000379:methods*
chemical_list: D001688:Biological Products; D003516:Cycloparaffins; D004364:Pharmaceutical Preparations; D011108:Polymers