Impurities in drug substances (DS) and drug products (DP) must be continuously controlled and monitored in order to safeguard the quality and safety of the patient. Reporting, identification, and qualification thresholds for impurities and setting acceptance criteria are available in regulatory guidance. When during routine quality control a new or previously unidentified impurity suddenly emerges above the identification or qualification threshold, the impurity needs to be identified, often under time pressure. One of the common analytical strategies and unquestionably a powerful tool for the identification of impurities is high-resolution accurate mass spectrometry (HRAM MS) in combination with tandem mass spectrometry (MS/MS) for structural elucidation. However, not all compounds that are responsive to LC/UV are equally responsive to LC/MS, especially in the case of leachable impurities. Hence the analytical toolbox for impurity identification should not be limited to LC/MS alone.

In this presentation, this will be demonstrated with case studies where unexpected impurities in drug products were eventually identified as leachables using an expanded mass spectrometry toolbox.

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