期刊
JOURNAL OF CHROMATOGRAPHY A
卷 1492, 期 -, 页码 49-54出版社
ELSEVIER SCIENCE BV
DOI: 10.1016/j.chroma.2017.02.062
关键词
Extractables; Single-use films; Upstream monitoring; bDtBPP; Disposables; UPLC
资金
- Science Foundation Ireland (SFI)
- European Regional Development Fund [13/SP SSPC/I2893]
- Science Foundation Ireland (SFI) [13/SP SSPC/I2893] Funding Source: Science Foundation Ireland (SFI)
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 220 nm. The method limits of detection were between 16 mu g L-1 and 60 mu g L-1, repeatability was %RSD <= 1.8 and linearity was R-2 >= 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((R)) 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. (C) 2017 Elsevier B.V. All rights reserved.
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