HS-GC-MS:

  • Toluene
  • Methylethyl ketone (MEK)
  • Octamethylcyclotetrasiloxane
  • Toluene-d8 (internal standard).

GC-MS:

  • N-Octane (and/or Eicosane)
  • Butylated hydroxytoluene(BHT)
  • Phenanthrene-d10 (internal standard).

LC-UV:

  • Bisphenol A (BPA)
  • Irganox™ 1010

LC-MS:

  • 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.