Identification of Unknown Impurities

The identification of pharmaceutical impurities is a critical analytical activity in the drug development process. The aim is to fully elucidate the chemical structures of unknown pharmaceutical impurities present above a certain concentration in medicinal substances and products. Knowledge of the chemical structure of an impurity is essential in order to assess the toxicological implications and to gain an understanding of how the impurity formed. Furthermore, knowledge of the formation mechanism is critical for improving the synthetic chemical processes and optimizing the drug’s formulation to reduce or eliminate the impurity. Mérieux NutriSciences proposes strategies for the identification of pharmaceutical impurities using various approaches and instruments, including:

• Method Analytical Transfer
• Non-MS compatible method adaptation for MS analysis
• HRMS MS/MS analysis for accurate mass determination
• Structure estimation based on accurate mass and fragmentation
• Isolation and/or enrichment of the impurity (if needed)

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