Selcia was approached by a customer who required storage stability/ mass balance on their natural product for a registration dossier to be submitted for regulatory approval of the compound. As the compound was a mixture of components with one key active component the customer was concerned that 40% of the mass balance was unaccountable for after 6 months stressed (40oC) storage. The target active component has no natural isotope ratio and the majority of the anticipated degradation products were already present in the extract. Therefore Selcia proposed a 14C mass balance study to quantitatively follow the key active component and its breakdown on storage. Additional 13C labelling would aid elucidation of the degradants. The presentation will take the form of a case study on how a mixture of 14C, 13C and unlabelled active compound, was used to generate an artificial isotope ratio for structural elucidation of the breakdown products resulting in a novel test system for following the natural product storage stability. The 14C label component helps to target MS peaks of interest and provides mass balance details. The 13C label provides a ‘handle’ for the structural elucidation.

Case study: Natural product stability

256th National Meeting (2018)

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