N-Nitrosoethyl-n-propylamine is an N-nitroso derivative of the secondary amine, which is a highly characterized reference material that meets stringent regulatory standards set for nitrosamine compounds, including those set by USP, EMA, JP, and BP. This nitroso standard is essential for a variety of applications, such as analytical method development, method validation (AMV), and Quality Control (QC), particularly in the context of API and raw material production. It is suitable for use in both Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA). This nitrosamine standard helps establish detection limits, quantify impurity levels, and ensure trace nitroso impurities in pharmaceutical products remain within FDA and EMA safety limits.
References
NISHIE, K. ?Phototoxicity and Differential Hepatotoxicity as Biological Indicators of Nitrosamine Activity.? Toxicology and Applied Pharmacology, vol. 23, no. 4, Dec. 1972, pp. 680?91, https://doi.org/10.1016/0041-008x(72)90108-1.?
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