Falsified Medicine and Counterfeit Medicine Analysis

Comprehensive analytical and physical investigations of falsified medicines or counterfeit medicines

In July 2011, the EU strengthened the protection of patients and consumers by adopting the Falsified Medicines Directive, aimed at preventing falsified medicines entering the legal supply chain. Falsified Medicines can be viewed as a health threat as they could contain low quality or the wrong ingredients or active ingredients (APIs) in the wrong doses. They may also be deliberately and fraudulently mislabelled and packaged with respect to their identity. Counterfeit medicines are medicines that do not comply with intellectual-property rights or that infringe trademark.

Intertek's pharmaceutical investigative analysis expertise is ideally positioned to address the highly technical issues in investigating the increasingly sophisticated falsified medicines or counterfeit medicines being discovered in the supply chains. Our Pharmaceutical analysis laboratory network employs a wide scope of 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 to explore and assist in the identification of fake medicines.

 
Chemical and physical pharmaceutical investigations:

• Determine presence of active pharmaceutical ingredients (APIs) present by NMR, GC-MS, LC-MS
• NMR Analysis of counterfeit drugs
• Determine the levels of APIs present
• Dissolution testing according to Eur.Ph. or USP for tablets
• Screen for excipients and other ingredients present e.g. coating materials
• Impurity profiling and impurity identification
• Screen for organic volatiles / residual solvents by GC-MS
• Physical 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
   

Related Services:

• Expert Witness and Intellectual Property Support for Pharmaceuticals

Contact us to see how Intertek can help your organization with Falsified Medicine and Counterfeit Medicine Analysis.