Nature's Fingerprint - Intrinsic Pharmaceutical Product and Process Authentication

Nature's Fingerprint(R)/Molecular Isotope Technologies LLC is a pharmaceutical product and process authentication firm that takes advantage of naturally-occurring tracers to mitigate counterfeiting and process patent infringement.

In the last five years, we have shown the utility of ambient stable isotopes for identifying pharmaceutical materials (product authentication) and elucidating the synthetic process that was used to manufacture them (process authentication). Since then, we have completed a complete mathematical description of the isotopic compositions of all of the precursors and products in a synthetic pathway from the raw starting materials through intermediates to products. Product authentication, or "isotopic fingerprinting," uses precise measurements of ratios of 13C to 12C, 15N to 14N, etc. to uniquely characterize authentic products, thus enhancing assessment of authenticity. Process analysis examines the mechanisms responsible for isotopic differences between reaction intermediates and products during synthesis. It provides information about process understanding via the synthetic routes employed and is thus an active forensic tool for process patent protection.

The four factors that control the isotopic compositions of synthetic products are the stoichiometries of the reactants, the isotopic compositions of the starting materials and precursors, the isotope effects associated with the synthetic reactions, and the extent to which precursors are quantitatively transformed to yield products. To discuss these factors systematically, we explore mass balances, isotope effects and the resulting isotopic fractionations and isotopic budgets within a complete synthetic pathway. A numerical example is presented of the isotopic record of a reaction sequence with four synthetic steps that generates large isotopic fractionations (>2‰) and easily measurable values. Collectively these factors can be utilized as a tool for PAC and to investigate and mitigate cases of process patent infringement.

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