Analytical Solutions for the accurate determination of Nitrosamines produced in the manufacture of APIs and Drugs

Presence of nitrosamines in pharmaceuticals is one of the most recent challenges that pharmaceutical industry has been experiencing. Regulatory agencies have been coming up with various guidance documents for addressing this challenge. The purpose of this talk is to provide an overview of current regulations to control nitrosamines in pharmaceuticals and to Agilent solutions to meet the regulatory guidelines. This talk would provide an overview about our solutions using Agilent Triple quadrupole liquid chromatography mass spectrometry, gas chromatography mass spectrometry and time of Flight liquid chromatography mass spectrometry for analyzing nitrosamine impurities.