Authentication of pharmaceutical vials

Publication date: 1 June 2019

Source: Talanta, Volume 198

Author(s): Klara Dégardin, Marguerite Jamet, Aurélie Guillemain, Tobias Mohn

Abstract

Packaging analysis is an important step in the authentication of medicines. All types of medicines are nowadays targeted by the counterfeiters, and among them, vials of injectable medicines. This type of pharmaceutical product is often a combination of fake parts and genuine but stolen, expired, reused and/or manipulated parts. For this reason, while the visual comparison with references is necessary to identify the packaging, it is sometimes difficult to see visual differences for each of the parts that compose a pharmaceutical vial. Several analytical tools were successfully tested to support the investigation of 31 counterfeited vials. Moreover eight counterfeited vials originating from different seizures could be linked based on the chemical or elemental composition of the different vial parts. Raman spectroscopy and microscopy, X-ray fluorescence spectroscopy, Infrared spectroscopy and optical microscopy proved especially efficient to support the visual comparison for the authentication of counterfeited flip off caps, aluminium crimping caps, stoppers, glass vials and vial labels and to detect links between the counterfeits at each of these levels. This last information can be especially useful for on-going investigations. The understanding of how the packaging was faked and manipulated could also be provided, which is also very valuable for prevention purposes, for example for the design of a more robust – and therefore more difficult to counterfeit – packaging.

Graphical abstract

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