App Notes 301 & 302: The Benefits Provided by 2D GC & Automated Sample Preparation When Applied to Extractable and Leachable Analysis When Evaluating Rubber Extracts


30th March 2023

Extractables and Leachables (E+L) studies involve the analysis of extracts of complex matrices such as rubbers and plastics, used in drug storage and delivery devices as well as medical devices. The resulting chromatograms can be complex and present difficulties with spectral deconvolution, which needs to be used to ensure that no potentially harmful extractable or leachable species are missed. Guidelines and protocols such as those set out in ISO 10993-18 and USP<665> set out how testing should be performed.

Data analysis for gas chromatography (GC) in E+L can be particularly challenging since chromatograms of rubber or plastic extracts can be complex. This presents a challenge for traditional one-dimensional chromatographic techniques. In these cases, two-dimension 2D GC can provide a solution for enhanced chromatographic separation. 2D GC also paves the way for statistical data analysis techniques such as Fisher-ratio Tile-based analysis and principal component analysis (PCA) provided by LECO’s ChromaTOF® Tile.

The work set out in application notes 301 and 302 talk about the benefits provided by 2D GC and automated sample preparation when applied to E+L analysis when evaluating rubber extracts. A fully automated dispersive liquid-liquid microextraction method was also developed for use in a simulant solution study the results of which were compared using ChromaTOF® Tile and PCA to enable identification of unique features with the different extraction types.

If you would like to know more, please see link to the application note or contact us.