Determination of Elemental Impurities in Sorbitol

This technical report focuses on the determination of elemental impurities in sorbitol, which is commonly used as a pharmaceutical excipient in oral medication formulations. The report outlines the significance of quality control for trace elemental impurities in sugar solutions utilized as excipients. It describes the analytical methods employed, specifically the use of Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES) and the PlasmaQuant 9100 Elite system, which offers high sensitivity and matrix tolerance. The report details the sample preparation process, including the dilution of sorbitol samples and calibration methods. It also presents results indicating low limits of quantification for potentially toxic elements such as arsenic, cadmium, mercury, and lead, all of which were found below the respective limits of detection. The findings suggest that the method provides accurate and precise results, meeting the requirements set forth by the European Pharmacopoeia. Furthermore, the report highlights the advantages of using ICP-OES over traditional methods, emphasizing efficiency and reliability in analyzing pharmaceutical excipients.