Sustainability in Analytical Chemistry Illustrated by Pharmaceutical Nitrosamine Testing.

ABSTRACT: Following the valsartan scandal in 2018, the testing of drug substances and drug products for N-nitrosamines has become a critical and mandatory quality control measure. The European Pharmacopoeia chapter 2.5.42 currently describes three analytical methods for this purpose: HPLC-MS/MS, GC-MS, and GC-MS/MS. The US Pharmacopeia monograph 〈1469〉 adds four other methods, LC-high-resolution mass spectrometry (HRMS), headspace GC-MS, LC-MS/MS, and GC-MS/MS. In addition, our group has developed a universal method on the basis of supercritical fluid chromatography (SFC), capable of separating 16 different N-nitrosamines within just 4 min. These eight methods differ significantly in terms of sustainability, with particular emphasis on the reagents used, the separation techniques employed, and their

SUBMITTER: Bredendiek F 

PROVIDER: S-EPMC12905522 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature