NITROSAMINE IMPURITIES IN PHARMACEUTICAL DOSAGE FORM: A REVIEW Authors: Sonawane T* And Khristi A
ABSTRACT
The FDA and other international agencies conducted a thorough study of nitrosamine
contamination in the impacted APIs and drug products after they were found in various types
of drug goods. Nitrosamine impurities are potent, broad acting carcinogens which if present
above the safety levels can cause serious harm. This review discusses the background of the
nitrosamine reports and its chemistry. Various official and reported analytical methods for
quantification of nitrosamine impurities in different drug products and drug substances are
mentioned below.
Keywords: Analytical method development, carcinogen, GC-MS, LC-MS/MS, Nitrosamine Publication date: 01/02/2024 https://ijbpas.com/pdf/2024/February/MS_IJBPAS_2024_7781.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2024/13.2.7781
