Ethylene oxide is a very toxic volatile organic compound (VOC) used as sterilization agent due to its bactericidal, sporicidal, and virucidal properties, while being compatible with a wide range of biomaterials. However, it is also an important raw material for the manufacture of polymeric materials used in the pharmaceutical industry (polyethylene oxide) and occurs as an impurity in polyethylene glycol (PEG), which is widely uses as an excipient.

Compendial methods describe gas chromatography (GC) analysis of ethylene oxide in PEG excipients, such as Polysorbate 80. The workflow is protracted due to (1) a six-hour purification step that removes ethylene oxide from a PEG sample that will be used as a blank and for matrix matching, and (2) a 38-minute GC run-time.

Selected ion flow tube mass spectrometry (SIFT-MS) analysis is much faster and it is significantly more sensitive, eliminating matrix matching to be eliminate. Hence SIFT-MS provides a much more streamlined workflow for Polysorbate 80 testing. Depending on your current workflow, with SIFT-MS you can have your first test results 5- to- 11-times faster (within 85 minutes) than GC and you could increase your daily throughput 9- to 14-fold!

Download the new Syft application note to learn more.