A Fast, Simplified Approach to Quantitative Headspace Analysis of Volatile Impurities in Drug and Packaging Products

6 months ago

Read the cover story in the September 2023 issue of The Column by LCGC which describes how multiple headspace extraction (MHE) is readily implemented with automated headspace-SIFT-MS to reduce sample preparation and shorten run times in workflows using styrene, formaldehyde, and N-nitrosodimethylamine (NDMA) analyses in polystyrene polymer, gelucire excipient, and ranitidine drug products. 

Abstract:

Multiple headspace extraction (MHE) quantifies volatile impurities in condensed-phase samples for which matrix-matched calibration standards are difficult or impossible to prepare. However, it is costly for conventional chromatographic techniques because it requires multiple analyses of each sample. In contrast, application of direct-injection mass spectrometry—in the form of selected ion flow tube mass spectrometry (SIFT-MS)—can transform MHE into a cost-effective analytical approach because headspace analysis is faster and correlation of the first injection to full MHE analysis is stable for several weeks. This article demonstrates enhanced MHE workflows using styrene, formaldehyde, and N-nitrosodimethylamine (NDMA) analyses in polystyrene polymer, gelucire excipient, and ranitidine drug products, respectively.

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