Determination of Extractables in Pre-filled Injectable Pens for Biopharmaceuticals by GC-MS and UPLC-QTOF-MS
Non targeted screening of extractables in three biopharmaceutical pre-filled injection pens was conducted with ultra-high performance liquid chromatography tandem quadrupole time of flight mass spectrometry(UPLC-QTOF-MS)and gas chromatography tandem quadrupole mass spectrometry(GC-MS)techniques.Based on the actual use of the injection pens,the components were extracted as a whole using four extraction agents at 70 ℃ for 4 d.By setting an analysis evaluation threshold(AET)and utilizing a database of extractables combined with manual spectral analysis,a total of 29 organic compounds were detected,including antioxidants,plasticizers,lubricants,and other components.Among them,27 substances were detected in injection pens with ordinary halogenated butyl rubber stoppers,and 4 extractables were detected in injection pens with coated rubber stoppers.The list of extractables obtained in this study can provide data references for subsequent compatibility studies.
NETL
NSTL
万方数据
