Process Authenticity: Isotopic Pedigree® IsoPedigreeSM Identification
Process Patent Protection / Process Consistency / Process Analytical Chemistry
The figure below illustrates that in many synthetic reactions the consumption of the reactants may be incomplete, resulting in products whose isotopic compositions are disproportionate to the original isotopic compositions of the reactants. This disproportion of the original mass and isotopic composition to the product is known as “fractionation” – or, more formally as isotopic fractionation. Isotopic fractionation is the fundamental mechanism which underlies the concept of process consistency and process patent protection as described in Jasper et al., 2005. Many reactions each have their own characteristic isotopic fractionations for each isotope involved in a synthetic reaction, the sum of which is referred to as the Isotopic Pedigree® / IsoPedigreeSM Identification of the synthetic pathway. The problems of pharmaceutical Product and Process Infringement are illustrated here:
