Applications > Pharmaceutical

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Stable isotope analysis is becoming increasingly important in pharmaceutical operations such as batch quality control, product identification, and synthetic pathways. Because these analyses do not require anything to be added to or changed within the compounds, they offer an improvement on other fingerprinting techniques. For example, this approach provides a means for product identification and production quality control without changing the original compound by adding dyes, markers, or other chemical adjustments.

Using elemental analyzer/isotope ratio mass spectrometry (EA/IRMS) or thermal conversion-EA/IRMS (TCEA/IRMS), active pharmaceutical ingredients (API) can be fingerprinted from different manufacturers by graphically observing the isotopic ratio patterns between the various elements of carbon, hydrogen, oxygen, nitrogen, and sulfur. By using isotope data, for instance, it may be possible to differentiate various world sources of pharmaceuticals and their manufacturing processes.

Suggested Readings
J. P. Jasper, B.J. Westenberger, J.A. Spencer, L.F. Buhse, and M. Nasr, "Stable Isotopic Characterization of Active Pharmaceutical Ingredients," Journal of Pharmaceutical and Biomedical Analysis, Volume 35, Issue 1, April 2004, Pages 21-30.

I. Stanimirova, M. Daszkowski, E. Van Gyseghem, F.F. Bensaid , M. Lees, J. Smeyers-Verbeke, D.L Masart, and Y. Vander Heyden, "Chemometrical Exploration of an Isotopic Ratio Data Set of Acetylsalicylic Acid," Analytica Chimica Acta, Volume 552, 2005, Pages 1-12.

The following web links are to Molecular Isotope Technologies, an affiliate of Isotech, who specializes in the use of stable isotope analysis for pharmaceutical applications.

Using stable isotopes to detect pharmaceutical counterfeiting

Using isotopic analysis to track fractionation in synthetic pharmaceutical manufacturing processes

Using isotopic analysis in process patent protection

Isotopic Fingerprinting of Solids and Liquids (PDF)

Information on organic solids and liquids analysis