Identification of Substandard or Falsified Topical Medicines from Guinea Conakry: A pilot Study

Substandard and falsified medical products represent a growing global public health concern. According to the World Health Organization, substandard medicines are authorized products that fail to meet quality standards, whereas falsified medicines deliberately misrepresent their identity or composition. Both may contain incorrect amounts of active pharmaceutical ingredients (APIs), undeclared substances, or no active ingredient, leading to therapeutic failure and potential health risks. This study aimed to develop and validate mass spectrometry-based methods for the identification of substandard or falsified topical medicines from Guinea Conakry by assessing discrepancies between declared and measured APIs. Specificity, linearity, precision, accuracy, matrix effect and stability at room temperature and after freeze-thaw cycles were evaluated. Method reliability in semi-solid matrices was also assessed through the analysis of commercially authorized Italian topical medicines. A total of N=13 APIs were quantified by LC-MS/MS or GC-MS in N=45 dermatological products (creams, gels, ointments and pastes).n summary, 35% of the analyzed products were compliant with the API concentration declared on the label, whereas 49% and 15% showed higher and lower API contents, respectively, suggesting the need for enhanced quality surveillance.