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Article

N-nitrosamine impurity risk assessment in pharmaceuticals: Utilizing In vivo mutation relative potency comparison to establish an acceptable intake for NTTP.

Regulatory toxicology and pharmacology : RTP - 1 Sept 2024

Powley Mark W, Sobol Zhanna, Johnson George E, Clark Robert W, Dalby Stephen M, Ykoruk Bridget A, Galijatovic-Idrizbegovic Alema, Mowery Mark D, Escobar Patricia A

Abstract excerpt

The finding of N-nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA) in marketed drugs has led to implementation of risk assessment processes intended to limit exposures to the entire class of N-nitrosamines. A critical component of the risk assessment process is establishing exposure limits that are protective of human health. One approach to establishing exposure limits for novel N-nitrosamines is to...

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Identifiers

PMID: 39067806
DOI: 10.1016/j.yrtph.2024.105681

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PubMed metadata and Literature Corpus relationships. Corpus snapshot updated 7 Sept 2026. Manifest publication-graph-cohort-2026-09-08.1.

Source receipt: pubmed, retrieved 7 Sept 2026.

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