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Analytical Development Group Leader
Lúcia Volta e Sousa
PhD Student / Analytical Chemist
Elemental impurities analysis has a great importance within pharmaceutical realm due to its impact on the quality, safety and efficacy of drug product and substances. These impurities can include catalysts and environmental contaminants that may be present in drug substances, excipients or drug product. For that reason, it is necessary to have a rigid control, during the manufacturing process in order to assure that the final product is within the specification limits described in the USP chapter <232> and recently approved ICH Q3D guideline. There are two procedures acknowledge by USP that can be used to analyze and control these materials, as ICP-MS and ICP-AES. These techniques are expensive and most of the times are not available in every manufacturing sites. According to USP <233> acceptable alternative procedures that meet validation requirements can be used. An alternative Microwave / UPLC / UV-VIS provides a powerful, advantageous and fast solution for heavy metals determination with improvements in terms of time and costs. The breakthrough is the use of microwave based digestion to obtain a universal method that can be applied to any organic matrix. The use of a Quality by Design approach will allow for a better understanding of the method design space and a more effective method development.