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Proceedings Paper

Molecular isotopic engineering (MIE): industrial manufacture of naproxen of predetermined stable carbon-isotopic compositions for authenticity and security protection and intellectual property considerations
Author(s): J. P. Jasper; P. Farina; A. Pearson; P. S. Mezes; A. D. Sabatelli
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Paper Abstract

Molecular Isotopic Engineering (MIE) is the directed stable-isotopic synthesis of chemical products for reasons of product identification and of product security, and also for intellectual property considerations. We report here a generally excellent correspondence between the observed and predicted stable carbon-isotopic (δ13C) results for a successful directed synthesis of racemic mixture from its immediate precursors. The observed results are readily explained by the laws of mass balance and isotope mass balance. Oxygen- and hydrogen isotopic results which require an additional assessment of the effects of O and H exchange, presumably due to interaction with water in the reaction solution, are addressed elsewhere.

A previous, cooperative study with the US FDA-DPA showed that individual manufacturers of naproxen could readily be differentiated by their stable-isotopic provenance (δ13C, δ18O, and δD; ref. 1). We suggest that MIE can be readily employed in the bio/pharmaceutical industry without alteration of present manufacturing processes other than isotopically selecting and/or monitoring reactants and products.

Paper Details

Date Published: 13 May 2016
PDF: 8 pages
Proc. SPIE 9863, Smart Biomedical and Physiological Sensor Technology XIII, 98630M (13 May 2016); doi: 10.1117/12.2228100
Show Author Affiliations
J. P. Jasper, Molecular Isotope Technologies, LLC (United States)
P. Farina, Canaan Partners (United States)
A. Pearson, Harvard Univ. (United States)
P. S. Mezes, Mezes Consulting (United States)
A. D. Sabatelli, Dilworth IP, LLC (United States)


Published in SPIE Proceedings Vol. 9863:
Smart Biomedical and Physiological Sensor Technology XIII
Brian M. Cullum; Douglas Kiehl; Eric S. McLamore, Editor(s)

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