Nitrosamine

N-Nitrosamines are a class of indirect acting mutagens, as their metabolic degradation leads to the formation of the DNA-alkylating diazonium...

N-nitrosamines (NAs) are a class of compounds of which many, especially of the small dialkyl type, are indirect acting DNA...

See the latest issue of Fuji Chemical Industries Technical Newsletter: It presents Fujicalin®, a low-risk solution for mitigating nitrosamine risks in...

A. FDA Issues notice on “Identification, Assessment, and Control of Nitrosamine Drug Substance-Related Impurities (NDSRIs) and requests comments”. While the...

Abstract The onset of the N-nitrosamine (NA) saga in 2018 was chiefly related to certain small dialkyl N-nitrosamines originating from the synthesis...

Abstract The detection of N-nitrosamine impurities in medicines and the recent emergence of nitrosamine drug substance related impurities (NDSRIs) has posed...

Abstract Risk control for nitrosamine impurities in drug products is currently a major challenge in the industry. Nitrosamines can form...

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1. Introduction The issue of Nitrosamine impurities in drug and excipient manufacturing has become a significant concern for the pharmaceutical...

N-nitrosamines are likely human carcinogens. After N-nitrosamine contaminants were detected in pharmaceutical products in 2018, regulatory authorities set a framework for the...