Analysis of organic volatile impurities as a forensic tool for the examination of bulk pharmaceuticals

This discussion offers an overview of some formally accepted methodology in the USA for the determination of organic volatile impurities in pharmaceuticals. Particular advantages of equilibrium headspace sampling with capillary gas chromatography for this task are outlined and some important considerations are expressed. Specific adaptations which we have made for forensic applications are described along with mention of select applications within the context of the detection of the counterfeiting of bulk pharmaceuticals. Finally, a brief description is provided of statistical techniques which can be used to effectively manipulate multivariate data sets for purposes of distinguishing between the manufacturers of a product based upon impurity profiles.