High Sensitive and Accurate Analysis of Nitrosamines Using GC/MS/MS

User Benefits

- Analyze trace quantities of nitrosamines with state-of-the-art detector. - MRM measurements eliminate matrix interferences to ensure reliable target compound detection. - Superior reproducibility helps to ensure reliable laboratory operations.

Introduction

In 2018, more than the permitted quantities of carcinogenic components, N-nitrosodimethylamine (NDMA) and N- nitrosodiethylamine (NDEA), were detected in a valsartan drug substance. Since then, a demand for analyzing nitrosamines, not only in drug ingredients but also in pharmaceuticals, has been increasing. According to the International Agency for Research on Cancer (IARC), NDMA and NDEA belong in Group 2A substances that are probably carcinogenic to humans. In the case of the ICH M7 guideline1), NDMA and NDEA are equivalent to a class 1 as carcinogenic controlled impurities that must be controlled within allowable limit values specified specifically for the respective compounds. In the case of GC/MS for analysis, direct injection is well-suited for simultaneous analysis of NDMA, NDEA, and other nitrosamines. This Application News describes simultaneous analytical method for five kinds of nitrosamines using a triple quadrupole gas chromatograph mass spectrometer system and indicates the corresponding results.

November 26, 2021 GMT