Falsified Medicine and Counterfeit Medicine Analysis

Addressing health risks posed by falsified medicines or counterfeit medicines through comprehensive chemical analysis and physical investigations

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.

Our falsified medicine 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. 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

Case Study: NMR Analysis for Falsified or Counterfeit Drugs

Intertek support pharmaceutical clients by applying NMR technology to identify and quantify active pharmaceutical ingredients (APIs) in drug products.

NMR Screening Methodology

The methodology typically involves solvent extraction and quantification using appropriate internal standards. These methods have highlighted cases where APIs were completely absent from the product and instances where the API levels were at major variance from the stated dose. When issues such as these are identified through screening, it is then important to validate methods before investigating further.

NMR Analysis Services

Our laboratories provide advanced NMR analytical investigations of falsified medicines. State-of-the-art instrumentation combined with experienced scientists, who can interpret and design advanced experiments, position us to offer accurate and reliable data and troubleshooting during complex scientific investigations. The NMR team provides a highly efficient service, including an overnight service with access to automatic web-enabled analytical results via a secure server (similar MS services are also available). The instruments are qualified to both GLP and cGMP standards, enabling NMR data to be used in regulatory projects and pharmaceutical quality control.