Counterfeit Drug Analysis

Counterfeit drug analysis is critical to combating the illicit market for counterfeit and fake medications which is a global industry worth billions, causing significant economic harm and posing serious health risks to the public. These risks include direct toxicity, ineffective treatments. To combat this challenge, there is a need for advanced analytical techniques that can rapidly test and identify suspicious medicines particularly in light of an increasing frequncy of falsified medicines 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.

Counterfeit drug analysis expertise

Our counterfeit drug analysis expertise is ideally positioned to address the highly technical issues involved in investigating the increasingly sophisticated falsified medicines or counterfeit medicines being discovered in legitimate supply chains. As a key tool in our pharmaceutical supply chain surveillance for counterfeit medicines services, our laboratory network employ 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. 

Our counterfeit medicine testing laboratories include labs which provide analytical testing to Good Laboratory Practice (GLP) compliant requirements and are on the WHO list of Prequalified Quality Control Laboratories (since 2014) and hold Good Manufacturing Practice Compliant (GMP) certification and is FDA inspected. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.

Chemical and physical counterfeit pharmaceutical investigations

• Determine the 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