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 …

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 …

[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 …

Nitroso impurities in drug products: an overview of risk assessment, regulatory milieu, and control strategy

NA Charoo, S Dharani, MA Khan, Z Rahman - AAPS PharmSciTech, 2023 - Springer
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 …

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 …

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 …

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 …

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 …

A comprehensive review of sources of nitrosamine contamination of pharmaceutical substances and products

H Akkaraju, R Tatia, SS Mane, AB Khade… - Regulatory Toxicology …, 2023 - Elsevier
Abstratct N-nitrosamines are carcinogenic impurities most commonly found in groundwater,
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 …