Trace-Level Quantification in Nitrosamine Analysis For Drug Safety

Trace Level Quantification of 6 Nitrosamine (NSA) Impurities

Since 2018, nitrosamines (NSA) impurities have continually posed major challenges in the global pharmaceutical industry. USP has published relevant standards and supported its stakeholders to promote public health. Herein, read the published paper where USP elaborated on how trace-level analysis of NSA in commercially used organic solvents plays an important role in the control of NSA in the manufacturing of quality drug substances and drug products. The work was performed on Shimadzu’s GCMS-TQ8050 NX with AOC-20iPlus injector and AOC-20sPlus autosampler to achieve the desired selectivity and sensitivity criteria. Read the published paper now.