Analytical Methodologies to Detect N-Nitrosamine Impurities in Active Pharmaceutical Ingredients, Drug Products and Other Matrices
KM Manchuri, MA Shaik, VSR Gopireddy… - Chemical Research …, 2024 - ACS Publications
Since 2018, N-nitrosamine impurities have become a widespread concern in the global
regulatory landscape of pharmaceutical products. This concern arises due to their potential …
regulatory landscape of pharmaceutical products. This concern arises due to their potential …
[HTML][HTML] Determining recommended acceptable intake limits for N-nitrosamine impurities in pharmaceuticals: Development and application of the Carcinogenic …
NL Kruhlak, M Schmidt, R Froetschl, S Graber… - Regulatory Toxicology …, 2024 - Elsevier
N-Nitrosamine impurities, including nitrosamine drug substance-related impurities
(NDSRIs), have challenged pharmaceutical industry and regulators alike and affected the …
(NDSRIs), have challenged pharmaceutical industry and regulators alike and affected the …
AI in Predictive Toxicology
B Yingngam - AI-Powered Advances in Pharmacology, 2025 - igi-global.com
The field of toxicology is undergoing a significant transformation due to the integration of
artificial intelligence (AI). In addition to traditional reliance on empirical studies and animal …
artificial intelligence (AI). In addition to traditional reliance on empirical studies and animal …