Process Patent Protection: Characterizing Synthetic Pathways by Stable-Isotopic Measurements - Pharmaceutical Technology

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Process Patent Protection: Characterizing Synthetic Pathways by Stable-Isotopic Measurements
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..


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8. P.E. Sauer et al., "Compound-Specific D/H Ratios of Lipid Biomarkers from Sediments as a Proxy for Environmental and Climatic Conditions," Geochim. Comsochim. Acta 65 (2), 213–222 (2001).

9. Y. Chikaraishi and H. Naraoka, "Compound-Specific δD-δ13 C Analyses of n-Alkanes Extracted from Terrestrial and Aquatic Plants," Phytochem. 63, 361–371 (2003).

10. J.M. Hayes, "An Introduction to Isotopic Calculations," (National Ocean Sciences Accelerator Mass Spectrometry Facility, Woods Hole, MA, 2004), http:// http://www.nosams.whoi.edu/docs/IsoCalcs.pdf, accessed Jan. 22, 2007.

11. J.P. Jasper, "The Increasing Use of Stable Isotopes in the Pharmaceutical Industry," Pharm. Technol. 23 (10), 106–114 (1999).

12. J.M. Hayes, "Practice and Principles of Isotopic Measurements in Organic Geochemistry," (National Ocean Sciences Accelerator Mass Spectrometry Facility, Woods Hole, MA, 2002), http://whoi.edu/docs/IsoNotesAug02.pdf, accessed Jan. 22, 2007.

13. J.P. Jasper, "Quantitative Estimates of Precision for Molecular Isotopic Measurements," Rap. Comm. Mass Spec., 15, 1554–1557 (2001).

14. K.M. Scott et al., "Optimal Methods for Estimating Kinetic Isotope Effects from Different Forms of the Rayleigh Distillation Equation," Geochim. Cosmochim. Acta, 68 (3), 433–442 (2004).


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