[Analysis Case] Analysis of Nitrosamines (LC-MS/MS Analysis)
This is an example of conducting LC-MS/MS analysis (liquid chromatography-tandem mass spectrometry) of nine types of nitrosamines standard samples.
In recent years, N-nitrosodimethylamine, a carcinogenic substance, has been detected in sartan-based pharmaceuticals. According to the Ministry of Health, Labour and Welfare's notification titled "Self-Inspection Regarding the Risk of Nitrosamine Contamination in Pharmaceuticals (dated October 8, 2021)," nitrosamines in pharmaceuticals must be below specified limits, which requires the measurement of trace amounts of the relevant components. This document introduces a case of LC-MS/MS analysis (liquid chromatography-tandem mass spectrometry) of standard samples of nine types of nitrosamines mentioned in the notification. ■ Analysis Samples - Standard samples of nine types of nitrosamines ■ Analysis Conditions - Equipment: AB SCIEX SCIEX QTRAP 5500 SYSTEM - Ionization Method: ESI positive ion mode - Measurement Mode: MRM ■ Analysis Results For each nitrosamine, peaks at a concentration of 1 ng/mL, necessary for limit value evaluation, can be detected.
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