title: Development and validation of an ultra-performance liquid chromatography method for the determination of bis(2,4-di-tert-butylphenyl)phosphate and related extractable compounds from single-use plastic films.
abstract: A UPLC-UV method is described for the detection of bDtBPP and related breakdown compounds of Irgafos 168 from single-use bioprocessing bag films using a CSH (charged surface hybrid) fluoro phenyl column and UV detection at 220nm. The method limits of detection were between 16μgL-1and 60μgL-1, repeatability was %RSD≤1.8 and linearity was R2≥0.9992. The method was applied to an extractables and leachables test of three single-use bioprocessing bag films. bDtBPP and oxidised Irgafos were detected from all three films in the extractables study, but not in the leachables study. A comparison of whole bag and small scale film extractions demonstrated that the small scale extractions were more suitable for finding concentration per area of film and/or estimating total load of extractables in the entire bag. The feasibility of upstream monitoring of extractable and leachable compounds with the Waters PATROL UPLC System via a Flownamics®sampling probe was also tested with cell growth medium spiked with bDtBPP. bDtBPP was only detected in at-line injections or online injections when the probe membrane was removed indicating that with the current sampling interface, monitoring of extractables and/or leachables is limited to at-line sampling.
authors.affiliation: The National Institute for Bioprocessing Research and Training, Characterisation and Comparability Laboratory, Foster Avenue, Mount Merrion, Blackrock, Co., Dublin, Ireland.
authors.forename: Christine
authors.initials: C
authors.lastname: Ta
authors.affiliation: The National Institute for Bioprocessing Research and Training, Characterisation and Comparability Laboratory, Foster Avenue, Mount Merrion, Blackrock, Co., Dublin, Ireland; School of Chemical and Bioprocess Engineering, University College Dublin, Belfield, Dublin 4, Ireland. Electronic address: jonathan.bones@nibrt.ie.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Bones
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation / Q000379:methods*; D006863:Hydrogen-Ion Concentration; D010755:Organophosphates / Q000032:analysis* / Q000302:isolation & purification; D010969:Plastics / Q000737:chemistry*; D052616:Solid Phase Extraction; D013056:Spectrophotometry, Ultraviolet; D013696:Temperature
chemical_list: D010755:Organophosphates; D010969:Plastics; C000617831:bis(2,4-di-tert-butylphenyl)phosphate
keywords: Disposables; Extractables; Single-use films; UPLC; Upstream monitoring; bDtBPP