Simple Rapid Analysis of Formaldehyde Impurities in Gelucire

15 months ago

Formaldehyde is formed in polyethylene glycol (PEG) excipients through both autoxidation and thermal abuse. However, analysis using conventional HPLC is slow, due to both sample preparation and chromatographic separation steps. SIFT-MS provides real-time, direct, and selective analysis of formaldehyde by eliminating sample preparation and chromatographic separation.

The multiple headspace extraction (MHE) technique enables formaldehyde to be analyzed quantitatively in Gelucire excipient. The results obtained in this study demonstrate that SIFT-MS can screen temperature-sensitive ingredients such as Gelucire to confirm that they are safe to use in formulations. Full MHE-SIFT-MS gives a daily throughput six-fold higher than the equivalent HPLC methods, while throughput for static headspace analysis is at least ten-fold higher. You’ll also get

Download the new Syft application note on formaldehyde analysis to learn more about simplifying your formaldehyde analysis in excipients without any need to dissolve and derivatize.