Quantification of Active Pharmaceutical Ingredients (API) in commercialized drugs using elemental analysis (Metadata RADIATE TA Proposal 23003100-ST)

Proposal title "Quantification of Active Pharmaceutical Ingredients (API) in commercialized drugs using elemental analysis". Measurements carried out at the external beam set-up for cultural heritage of the INFN LABEC accelerator laboratory, from 19 till 23 June 2023. Hands-off mode. Drugs are composed of one or more active pharmaceutical ingredients (APIs) and auxiliary substances, the excipients. The API constitutes the therapeutic part of the drug while the excipients are neutral substances which facilitate the action of the active principle.<br> Counterfeiting can consist of right or wrong ingredients, without active ingredient or in insufficient quantity or even have falsified packaging. Although these counterfeits affect the different classes of drugs, the vast majority concern, antibiotics, treatments for asthma and the digestive system. <br> The experiment aimed to quantify the active pharmaceutical ingredients (API) of various drugs classes mainly the asthmatic drug, to confirm the quality of the used drugs and to detect any eventual impurities in the drug formulations. The studied drugs were: Janumet XR 100mg/1000 mg, Singular 10 mg, Reliefast 10 mg, Leukotris 10 mg, Lukast 10 mg, Tamsulosin hydrate 0.4 mg, Metformkin Mylan 500 mg, Glimepiride 4 mg, Lamotrigine Arrow Lab 50 mg, Spasmex 30 mg, Antiplex 75, Moducren 10 mg/2.5 mg/25 mg, Bantrin. External beam IBA measurements (PIXE, PIGE and EBS) were carried out on a set of 13 different drug samples as pressed pellets of 5 mm of diameter and as-is tablets. The used external beam set-up included two SDD detectors for PIXE analysis of low-Z and mid, heavy-Z elements; one HPGe detcteor for PIGE and one Si pin diode for EBS. The proton beam energy was 3 MeV and the measurements lasted 600 seconds. During the measurement the sample was moved so the beam scanned the sample surface to avoid local inhomogeneities. Apart from the drug samples, several thick standards (high-purity metals, glass reference materials) have been repeatedly analysed as well, both as standards for the quantitative analysis and for checking reproducibility and repeatability.