Fighting falsified medicines: The analytical approach.

ABSTRACT

Given the harm to human health, the fight against falsified medicines has become a priority issue that involves numerous actors. Analytical laboratories contribute by performing analyses to chemically characterise falsified samples and assess their hazards for patients. A wide range of techniques can be used to obtain individual information on the organic and inorganic composition, the presence of an active substance or impurities, or the crystalline arrangement of the formulation's compound. After a presentation of these individual techniques, this review puts forward a methodology to combine them. In order to illustrate this approach, examples from the scientific literature (products used for erectile dysfunction treatment, weight loss and malaria) are placed in the centre of the proposed methodology. Combining analytical techniques allows the analyst to conclude on the falsification of a sample, on its compliance in terms of pharmaceutical quality and finally on the safety for patients.