N-nitrosamines as “special case” leachables in a metered dose inhaler drug product
DL Norwood, JO Mullis, TN Feinberg… - PDA Journal of …, 2009 - journal.pda.org
N-nitrosamines are chemical entities, some of which are considered to be possible human
carcinogens, which can be found at trace levels in some types of foods, tobacco smoke …
carcinogens, which can be found at trace levels in some types of foods, tobacco smoke …
Practical and Science-Based Strategy for Establishing Acceptable Intakes for Drug Product N-Nitrosamine Impurities
KL Dobo, MO Kenyon, O Dirat, M Engel… - Chemical research in …, 2022 - ACS Publications
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 …
for the quality management of medicinal products. N-Nitrosamines are considered cohort-of …
[HTML][HTML] A nitrite excipient database: a useful tool to support N-nitrosamine risk assessments for drug products
R Boetzel, J Schlingemann, S Hickert, C Korn… - Journal of …, 2023 - Elsevier
N-Nitrosamine risk assessment and control have become an integral part of pharmaceutical
drug product development and quality evaluation. Initial reports of nitrosamine …
drug product development and quality evaluation. Initial reports of nitrosamine …
Nitroso impurities in drug products: an overview of risk assessment, regulatory milieu, and control strategy
Many nitrosamines have been recognized to be carcinogenic for many decades. Despite the
fact that several nitrosamine precursors are frequently used in the manufacturing of …
fact that several nitrosamine precursors are frequently used in the manufacturing of …
Analysis of volatile N-nitrosamines in commercial drugs
M Castegnaro, B Pignatelli, EA Walker - Food and Cosmetics Toxicology, 1981 - Elsevier
Various formulations of drugs containing aminopyramine, disulfiram or oxytetracycline were
analysed for volatile N-nitrosamines by gas chromatography using a chemiluminescence …
analysed for volatile N-nitrosamines by gas chromatography using a chemiluminescence …
Analysis of selected drug formulations for volatile nitrosamines
BA Dawson, RC Lawrence - Journal of the Association of Official …, 1987 - academic.oup.com
A number of selected drug formulations on the Canadian market were analyzed for A'-
nitrosodimethylamine (NDMA) and/Y-nitrosodiethylamine (NDEA) content by using a gas …
nitrosodimethylamine (NDMA) and/Y-nitrosodiethylamine (NDEA) content by using a gas …
Evaluating nitrosamines from elastomers in pharmaceutical primary packaging
B Boltres - PDA Journal of Pharmaceutical Science and …, 2022 - journal.pda.org
Nitrosamines have gained unexpected attention again, triggered by their discovery at
significant concentrations in some active pharmaceutical ingredients and pharmaceutical …
significant concentrations in some active pharmaceutical ingredients and pharmaceutical …
Current Threat of Nitrosamines in Pharmaceuticals and Scientific Strategies for Risk Mitigation
B Tuesuwan, V Vongsutilers - Journal of Pharmaceutical Sciences, 2023 - Elsevier
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 …
receptor blockers (ARBs) to wide range of medicines as the risk of contamination via the …
A comprehensive review of sources of nitrosamine contamination of pharmaceutical substances and products
Abstratct N-nitrosamines are carcinogenic impurities most commonly found in groundwater,
treated water, foods, beverages and consumer products. The recent discovery of N …
treated water, foods, beverages and consumer products. The recent discovery of N …
Quantitation of Reactive Nitrosating Agents in Pharmaceutical Excipients for N-Nitrosamine Risk Assessments
H Yamamoto, C Kagawa, T Nakajima… - … Process Research & …, 2023 - ACS Publications
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 …
that are capable of reacting with amines to afford N-nitrosamines, N-nitrosamine risk …