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Counterfeit analysis strategy illustrated by a case study.

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Summary
This summary is machine-generated.

Counterfeit medicines infiltrated Europe's supply chain. This study details analytical methods to identify fake drugs, revealing packaging tampering and altered chemical compositions in most samples.

Keywords:
analytical strategychemical compositionforensic intelligencemedicine counterfeitsprofiling

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Area of Science:

  • Pharmaceutical analysis
  • Forensic science
  • Analytical chemistry

Background:

  • Medicine counterfeiting poses a significant threat to public health and the pharmaceutical industry.
  • In 2014, counterfeit medicines were detected within the legitimate European supply chain, necessitating rapid analytical responses.

Purpose of the Study:

  • To outline an analytical strategy for investigating counterfeit medicine cases.
  • To establish criteria for rapid and comprehensive analysis of counterfeit pharmaceutical products.
  • To identify the methods used to detect manipulation and authenticate drug samples.

Main Methods:

  • Packaging evaluation, including comparison with genuine samples and identification of tampering signs.
  • Chemical analysis utilizing near-infrared (NIR) and infrared (IR) spectroscopy.
  • Capillary zone electrophoresis (CZE) and ultraviolet-visible (UV-Vis) spectrophotometry for authentication and compositional analysis.

Main Results:

  • Out of 20 analyzed samples, 17 were confirmed as counterfeit.
  • Counterfeits included manipulated genuine products (e.g., diluted with water) and one case with entirely fake components.
  • Evidence of tampering, such as added glue on packaging, was observed.

Conclusions:

  • The developed analytical strategy effectively identified counterfeit medicines and their characteristics.
  • Forensic intelligence analysis of data revealed links between cases and elucidated counterfeiter modus operandi.
  • The study advocates for large-scale chemical and packaging profiling of counterfeit drugs.