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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...
Pharma Solutions at IFF provides you access to one of the broadest microcrystalline cellulose (MCC) portfolios in the industry. Backed...
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...
USP has launched the newest tool in their suite of solutions to address the evolving nitrosamines crisis: the Nitrosamines Analytical...
The potential for active pharmaceutical intermediates and active ingredients to contain low levels of N-nitrosamines is a topic of continued interest...
Many nitrosamines have been recognized to be carcinogenic for many decades. Despite the fact that several nitrosamine precursors are frequently...
In mid-2018, N-nitroso-dimethylamine (NDMA) was unexpectedly detected in a valsartan active pharmaceutical ingredient (API). NDMA, like many other nitrosamines, is...
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