There are increasing occurrences of falsified medicines or counterfeit drug products entering legal healthcare supply chains around the world. Falsified medicines can be viewed as a health threat, as they may contain low quality or even the wrong ingredients, or alternatively, contain active pharmaceutical ingredients (APIs) in the wrong doses or not at all. They may also be deliberately and fraudulently mislabeled and packaged with respect to their identity. Counterfeit medicines are medicines that do not comply with intellectual property rights or are those that infringe a trademark. Various investigative analytical technology such as mass spectrometry (MS), infra-red (FTIR) spectroscopy, RAMAN spectroscopy, nuclear magnetic resonance (NMR) spectroscopy, gas chromatography - mass spectrometry (GC-MS), liquid chromatography - mass spectrometry (LC-MS) and more, are employed to explore and assist in the identification of fake medicines.
Chemical and physical counterfeit pharmaceutical investigations include: Determine presence of active pharmaceutical ingredients (APIs) present by NMR, GC-MS, LC-MS, Determination of the levels of APIs present, Dissolution testing according to Eur.Ph. or USP for tablets, Screening for excipients and other ingredients present, such as coating materials, Impurity profiling and impurity identification, Screen for organic volatiles / residual solvents by GC-MS, Solid state characterisation such as XRD analysis for API morphology, Microscopy investigation (FTIR, RAMAN, optical and Electron Microscopy (SEM)), Particulate shape and morphology, Thickness of coatings, Metals analysis and metals screening, LC-MS analysis to identify intermediates for patent litigation support.
Packaging investigations: Printed and Security ink analysis by gas chromatography, Paper and card testing, Surface chemistry investigations e.g. Time-of-Flight Secondary Ion Mass Spectrometry (ToF-SIMS), X-ray photoelectron spectroscopy (XPS), FTIR Microscopy.
A large number of samples have to be tested in order to maintain an appropriate assurance of drug quality and a high level of patient protection. Yet at the same time, pharmacopoeial analyses have become more and more expensive and only a few centers of excellence in some countries are currently available to perform them in the quantities required.