Practical and Science-Based Strategy for Establishing Acceptable Intakes for Drug Product N-Nitrosamine Impurities
Sign Up to like & getrecommendations! Published in 2022 at "Chemical Research in Toxicology"
DOI: 10.1021/acs.chemrestox.1c00369
Abstract: 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-concern compounds due to the potent carcinogenicity of many of the structurally simple chemicals… read more here.
Keywords: nitrosamine; drug product; practical science; nitrosamine impurities ... See more keywords
Nitrosamines, ICH Q3A-Q3E, Global Substance Registration System (GSRS), N-nitroso dimethyl amine (NDMA), Drug substance life cycle.
Sign Up to like & getrecommendations! Published in 2024 at "Current topics in medicinal chemistry"
DOI: 10.2174/0115680266278636240125113509
Abstract: Since their discovery in valsartan-containing drugs, nitrosamine impurities have emerged as a significant safety problem in pharmaceutical products, prompting extensive recalls and suspensions. Valsartan, candesartan, irbesartan, olmesartan, and other sartans have been discovered to have… read more here.
Keywords: substance; global substance; nitrosamine impurities; q3a q3e ... See more keywords
NAVIGATING NITROSAMINES: ORIGIN, DETECTING, ANALYSING AND REGULATING IMPURITIES IN PHARMACEUTICALS
Sign Up to like & getrecommendations! Published in 2024 at "International Journal of Applied Pharmaceutics"
DOI: 10.22159/ijap.2024v16i5.51376
Abstract: N-nitrosamines are carcinogenic impurities mostly found in groundwater, treated water, foods, beverages, and consumer products like processed meats, alcoholic beverages, cosmetics, and cigarette smoke. The recent discovery of N-nitrosamines in pharmaceutical products and subsequent recalls… read more here.
Keywords: origin detecting; nitrosamine impurities; nitrosamines origin; drug ... See more keywords
N-Nitrosamine Impurities in Ethalfluralin: Determination of an Overlooked Deleterious Source in Pesticides
Sign Up to like & getrecommendations! Published in 2023 at "Agriculture"
DOI: 10.3390/agriculture13051104
Abstract: N-nitrosamines are a class of carcinogenic chemical compound. Considering the large-scale application of agrochemicals globally, the elimination of N-nitrosamines from pesticides should be a priority for manufacturers and regulators. A set of methods was developed… read more here.
Keywords: determination overlooked; ionization; ethalfluralin determination; determination ... See more keywords
Simultaneous Determination and Quantification of NineNitrosamine Impurities in Semi-Solid Forms Using a GC–MS/MS Method
Sign Up to like & getrecommendations! Published in 2025 at "Separations"
DOI: 10.3390/separations12050120
Abstract: Many studies are being conducted on the detection of nitrosamine impurities in solid formulations. However, research on semi-solid formulations such as gels, ointments and creams is not common. In particular, excipients used to increase viscosity… read more here.
Keywords: method; nitrosamine impurities; semi solid; sample preparation ... See more keywords
A sensitive green analytical LC-MS/MS method for the quantification of trace levels of nine nitrosamine impurities in Zaltoprofen bulk drug
Sign Up to like & getrecommendations! Published in 2025 at "Journal of Applied Pharmaceutical Science"
DOI: 10.7324/japs.2026.244232
Abstract: Zaltoprofen, a selective cyclooxygenase-2 (COX-2) inhibitor and a member of the nonsteroidal anti-inflammatory drugs, has been associated with the formation of nitrosamine impurities under specific conditions involving secondary or tertiary amines and nitrite salts, particularly… read more here.
Keywords: method; nitrosamine impurities; quantification; sensitive green ... See more keywords