John P. Jasper

The authors' directed isotopic synthesis is one example of how molecular isotopic engineering can be used to predetermine the discrete isotopic ranges of biopharmaceutical products.

The authors describe the methods by which precise analyses of stable-isotopic abundances can be used in security and forensic applications for pharmaceutical materials. These methods include product and process authentication of raw materials, pharmaceutical intermediates, drug substances, formulated drug products, and synthetic pathways. Collectively, these methods can be used to investigate and mitigate patent infringement. In the future, more complete examples will be presented containing full isotopic results and the application of the methods described in this article.

The use of stable isotopic analyses to characterize drug products before they leave the manufacturer is explored as a means to identify counterfeit products.