High-Sensitivity Quantitative Analysis of Nitrosamines Using Triple Quadrupole LC/MS/MS

User Benefits

- High-sensitivity analysis supports the strict risk assessment required for nitrosamine impurities. - LC/MS/MS enables accurate quantitative analysis by providing a wide range of calibration curve concentrations and excellent linearity.

Introduction

The nitrosamine compounds NDMA and NDEA are classified as probably carcinogenic to humans (Group 2A) by the International Agency for Research on Cancer (IARC). This corresponds to a Class 1 impurities classification by the ICH M7 guideline on controls for impurities1) and requires control at or below a compound-specific acceptable limit. LC/MS/MS methods are included among analysis methods used for detecting nitrosamines published by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). This article describes an example high-sensitivity analysis of six nitrosamines, including NDMA and NDEA, performed by LC/MS/MS.

February 3, 2022 GMT