In recent years, N-nitrosamines were found as contaminants in several drugs, leading to their recalls. This resulted in more stringent manufacturing requirements to detect contaminants in complex pharmaceutical samples using liquid chromatography and mass spectrometry (LC-MS). However, identifying trace amounts of contaminants is challenging. To overcome the technical difficulties of this task, scientists optimize their LC-MS methods and instrumentation to enhance sensitivity and specificity.
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- Recent drug recalls related to N-nitrosamine contamination
- Challenges in detecting pharmaceutical sample contamination
- Optimal contaminant detection using proper sample prep and LC-MS methods