- Methylethyl ketone (MEK)
- Toluene-d8 (internal standard).
- N-Octane (and/or Eicosane)
- Butylated hydroxytoluene(BHT)
- Phenanthrene-d10 (internal standard).
- Bisphenol A (BPA)
- Irganox™ 1010
- A relevant standard of your choice to verify MS sensitivity.
Note: In the Best practices guide for evaluating leachables risk from polymeric single-use systems in biompharmaceutical manufacturing, a modified set of recommended standards was published, compared to Standardized extractables testing protocol for single-use systems in biomanufacturing published in 2014 (BioPhorum protocol)Methanol was replaced by Toluene and n-Octane was replaced by Eicosane. This has been implemented in the revised recommendations from BioPhorum on extractables testing of biomanufacturing equipment.
The SST requirements for LC-UV-MS are specified for ultraviolet (UV) detection. It is, however, recommended to use relevant compounds of your own choice to verify the MS performance, as Bisphenol A and Irganox 1010 may not ionize efficiently in all four mass spectrometry detection modes.