Quantification of Nitrite in Excipients and Chemicals: A Versatile and Highly Sensitive Method Using Headspace Gas Chromatography Coupled to Mass Spectrometry
The trace level quantification of nitrite in excipients and chemicals is of major interest to the pharmaceutical industry due to the formation of carcinogenic nitrosamines from potentially present secondary amines and nitrite in the API and/or drug product. The aim of this work was the development of a method for the quantification of nitrite down…