The risk assessment and control of N-nitrosamine impurities in medicines is a topic of great
concern for patients, regulators, and the pharmaceutical industry. This paper discusses a …

Highlights•The development of digital tools is vital to quantify nitrosamines acceptable
intake, rate of generation, and purge.•Solution-phase kinetic models are used to determine …

Given that pharmaceutical excipients contain traces of nitrosating agents (NO x; eg, nitrites)
that are capable of reacting with amines to afford N-nitrosamines, N-nitrosamine risk …

Risk control for nitrosamine impurities in drug products is currently a major challenge in the
industry. Nitrosamines can form during drug product manufacturing and storage through the …

The current global situation of nitrosamine contamination has expanded from angiotensin-II
receptor blockers (ARBs) to wide range of medicines as the risk of contamination via the …

N-Nitrosamine risk assessment of pharmaceuticals has moved from an initial focus on the
potential presence of known small-molecule N-nitrosamines such as N …

The recent discovery of nitrosamines within marketed drugs, such as Valsartan, has led to
changes within the regulatory landscape. Most notably, the requirement for a risk evaluation …

The potential presence of N-nitrosamines in medicinal products has become a matter of
concern for health authorities and pharmaceutical companies. However, very little …

The formation of nitrophenols by-products is still of major concern for the economics and
environmental impact of the industrial process of benzene (Bz) nitration to …

The potential for N-nitrosamine impurities in pharmaceutical products presents a challenge
for the quality management of medicinal products. N-Nitrosamines are considered cohort-of …