Nitrosamine impurities are the most challenging classes of pharmaceutical impurities. In this context the pharmaceutical industry has invested enormous effort in identifying, synthesizing, isolating, and characterizing these compounds. This is to support analytical method development, toxicological assessment, and regulatory compliance.
However, synthesizing nitrosamine impurities is a highly challenging process.
This article explores various synthesis methods, characterization, stability, and future challenges of nitrosamine impurities in the pharmaceutical industry.
Keywords: Nitrosamine impurity synthesis; API impurities; Pharmaceutical impurities; Nitrosamine characterization; Nitrosamine stability.