This webinar presents two case studies in the profiling of extractables from drug packaging container closure system component as well as single-use bioprocessing component analysis.
In the BioPhorum Operations Group (BPOG) recommendations for extraction conditions that should be employed for the profiling of extractables from single-use bioprocessing components, one of the solvent systems proposed is Polysorbate 80 (PS-80). This is a very challenging solvent from the point of view of the analysis by GC/MS or LC/MS. However, since PS-80 is an integral part of the formulation for many pharmaceutical products and is used to stabilize protein therapeutics in many pharmaceutical formulations including parenteral, ophthalmic, oral and topical preparations, it has become one of the most requested solvents for evaluating extractables profiles. The first part of this webinar will elucidate the analytical challenges associated with this solvent and provide some strategies developed using the Agilent LC-TOF and associated analysis software packages to help address some of these challenges.
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The second part of this webinar will present an extractables study and a subsequent simulation study conducted on multilayer IV bags used for packaging sterile water for injection (SWFI) and glycine buffer solution. The extracts in both studies were directly analyzed on an Agilent iFunnel LC/Q-TOF for characterization of non-volatile compounds. The high sensitivity and mass accuracy of the instrument allowed facile identification of compounds at ppb (ng/mL) levels. Identification of compounds was facilitated by Agilent E&L database and library. Non-volatile extractables detected in the simulation study were correlated to those observed in the extractables study.
