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What can you learn in relation to identifying the unknowns in extraction profiles at E&L Europe?

Highchem, Toxicon and Agilent Technologies discuss their methods for identifying unknowns in extraction profiles

How does the development and utilisation of cloud based libraries help with unknown contaminant identification?

Robert Mistrik is the founder and CEO of HighChem, Ltd., a privately owned scientific software company, which develops library and cloud systems, and builds large data collections of fragmentation knowledge, experimental spectra and organism specific biochemical data that are indispensible in modern pharmaceutical, metabolomic, forensic and environmental applications. Utilising a cloud-based library makes the inherently difficult tasks of compound identification, spectra interpretation and chromatogram deconvolution simple and understandable in order to open doors for a wide spectrum of scientists to new emerging fields.

How can understanding the chemistry and reactivity of halogenated rubber oligomers help in identifying unknowns in extraction profiles of exhaustive controlled extraction studies?

It is commonly known that halogenated rubber oligomers are a group of compounds which are often observed, both as extractables, in controlled extraction studies, as well as – in certain cases - as leachables in some drug products. Although there is an ongoing debate upon the toxicity of this group of compounds, it is a fact that these compounds are alkylating agents with a high reactivity for certain functional groups. These interactions have been widely observed – forming adducts with components of the drug products (API, Peptides, proteins, excipients). A second observation is that, when performing a controlled extraction study on rubbers with more aggressive solvents (like IPA, Hexane), a potentially longer list of UNKNOWNS is generated, both in GC/MS and LC/MS, of which the origin is not always very clear. The question now arises: knowing and understanding the high reactivity of these halogenated rubber oligomers, would it be possible that a group of these reported unknowns could be linked to reaction products of the oligomers with other rubber ingredients, such as curing agents, activators, accelerators…

Toxikon is currently running an R&D programme to systematically allow the halo rubber oligomers – which are available at Toxikon – react with other rubber ingredients under the typical conditions of rubber curing. Initial results of this R&D programme will be shared by Scientific Director, Dr Piet Christaens.

How can complex extractable leachable mixtures be profiled by comparing multiple ionization and separation methods with high resolution mass spectrometry, 3d data mining, differential analysis software and identification using MS/MS spectral libraries?

As drug product formulations continue to move from small molecule to Biologics, the complexity and the impact of potential extractable and leachable compounds on stability and safety continues to increase.  Being able to detect E/L in these complex mixtures can be a challenge due to the presence of oligomeric solubilizing agents and heterogeneity of higher molecular weight biologics. Extractable and leachable analysis routinely use GC/MS and LC/MS with various ionization methods.  For GCMS analysis many standard methods exist, with identification using commercially available EI libraries.  For LCMS analysis several challenges exist. This presentation from David Weil, Applications Scientist, Agilent Technologies will study the effect of many of these challenges.

Join all three experts and increase your knowledge on unknowns in extraction profiles at Extractables & Leachables 2015, this November in London. Register your place today