title: Isotopic 13C NMR spectrometry to assess counterfeiting of active pharmaceutical ingredients: site-specific 13C content of aspirin and paracetamol.
abstract: Isotope profiling is a well-established technique to obtain information about the chemical history of a given compound. However, the current methodology using IRMS can only determine the global (13)C content, leading to the loss of much valuable data. The development of quantitative isotopic (13)C NMR spectrometry at natural abundance enables the measurement of the (13)C content of each carbon within a molecule, thus giving simultaneous access to a number of isotopic parameters. When it is applied to active pharmaceutical ingredients, each manufactured batch can be characterized better than by IRMS. Here, quantitative isotopic (13)C NMR is shown to be a very promising and effective tool for assessing the counterfeiting of medicines, as exemplified by an analysis of aspirin (acetylsalicylic acid) and paracetamol (acetaminophen) samples collected from pharmacies in different countries. It is proposed as an essential complement to (2)H NMR and IRMS.
authors.affiliation: University of Nantes-CNRS, Chemistry and Interdisciplinarity: Synthesis, Analysis and Modeling, UMR6230, 2 rue de la Houssinière, BP 92208, F-44322 Nantes cedex 3, France.
authors.forename: Virginie
authors.initials: V
authors.lastname: Silvestre
authors.forename: Vanessa Maroga
authors.initials: VM
authors.lastname: Mboula
authors.forename: Catherine
authors.initials: C
authors.lastname: Jouitteau
authors.forename: Serge
authors.initials: S
authors.lastname: Akoka
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Robins
authors.forename: Gérald S
authors.initials: GS
authors.lastname: Remaud
mesh_terms: D000082:Acetaminophen / Q000032:analysis* / Q000592:standards; D001241:Aspirin / Q000032:analysis* / Q000592:standards; D002247:Carbon Isotopes; D009682:Magnetic Resonance Spectroscopy / Q000379:methods*; D011786:Quality Control
chemical_list: D002247:Carbon Isotopes; D000082:Acetaminophen; D001241:Aspirin