Servicio de Información Comunitario sobre Investigación y Desarrollo - CORDIS

Use of isotopic analyses (2H NMR and IRMS) to detect counterfeit molecules and patent infringement

Stable isotopes are (non-radioactive) naturally-occurring chemical tracers (13C, 2H, 15N) of synthetic or biosynthetic pathways. Measured at natural abundance level, this isotopic information provides a unique fingerprint of the active compound or of selected synthons that can be used to authenticate the synthetic process. These isotopic techniques are applied on a routine basis to the authentication of food products, for example to detect addition of sugar in fruit juice, to determine the natural status of an aroma molecule. The key innovative feature proposed here is the use of these techniques to trace the synthetic pathway that a molecule of pharmaceutical importance has undergone during its elaboration. This provides a means of proving that a product has or has not followed a patented process.
The techniques have been tested on generic molecules that are widely available throughout the world (aspirin, ibuprofen, paracetamol) demonstrating the potential of these methods for providing market intelligence. A number of other pharmaceutical compounds of interest have been included as test cases.
The expected benefits are to the pharmaceutical companies or to the European enforcement authorities in their attempt to clamp down on counterfeit medicines in Europe.

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Eurofins Scientific Analytics
Rue PIerre Adolphe Bobierre
44323 NANTES
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