The evaluation of Extractables and Leachables (E&L) is based on well-established industrial practices, reinforced by toxicological research. In hospital pharmacy, the lack of systematic E&L assessment, combined with the improper use of medical packaging, exposes frail and vulnerable patients to potentially toxic leachable compounds. This issue stems from a lack of awareness, financial constraints, and insufficient regulations.

To address this challenge, it is crucial to establish guidelines, implement analytical monitoring, and develop risk assessment workflows. This thesis highlights an innovative approach using UHPLC-HRMS and the DELTA database to identify and semiquantify leachable compounds. An optimized sample preparation method, tailored to hospital pharmacy compounding matrices, has been developed to enhance detection. The results indicate that certain packaging materials reach concerning toxicological thresholds, emphasizing the urgent need for stricter monitoring of materials used in hospital pharmacy.