Volatile compounds are common impurities in pharmaceutical products and are often of concern due to their toxicity. They can also represent a health and comfort hazard in both the outdoor and indoor environment. However, analysis using conventional chromatographic methods is slow, due to both sample preparation and chromatography.
Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) is a new analytical tool for real-time, selective, and economical trace gas and headspace quantification of volatile compounds, including chromatographically challenging ones such as formaldehyde, formic acid, and ammonia. But how do you approach analytical method validation for SIFT-MS so that the data can be used to support regulatory requirements? By applying a strategy in accordance with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Validation of Analytical Procedures: Text and Methodology Q2(R1) Guidelines (or “ICH Q2(R1)”) to direct analysis methods using SIFT-MS, successful validation is readily achieved. This is illustrated by utilizing formaldehyde analysis as a case study.
This webinar describes how SIFT-MS works, how it speeds up analysis, and how it has been validated successfully in accordance with ICH Q2(R1) Guidelines suitable for pharmaceutical applications, such as regulatory submissions where GMP compliance is essential.