An Agile and Accurate Approach for N-Nitrosamines Detection and Quantification in Medicines by DART-MS
Author:
Affiliation:
1. Federal University of Goiás, Institute of Chemistry, Goiânia, Goiás 74690-900, Brazil
2. Federal University of Paraná, Department of Chemistry, Curitiba, Paraná 80060-140, Brazil
3. SENS Advanced Mass Spectrometry, 05319-000 São Paulo, SP, Brazil
Funder
Funda??o de Amparo ? Pesquisa do Estado de Goi?s
Conselho Nacional de Desenvolvimento Cient?fico e Tecnol?gico
Coordena??o de Aperfei?oamento de Pessoal de N?vel Superior
Publisher
American Chemical Society (ACS)
Link
https://pubs.acs.org/doi/pdf/10.1021/jasms.4c00012
Reference51 articles.
1. Critical Analysis of Drug Product Recalls due to Nitrosamine Impurities
2. Practical and Science-Based Strategy for Establishing Acceptable Intakes for Drug Product N-Nitrosamine Impurities
3. Nitrosamine Contamination in Pharmaceuticals: Threat, Impact, and Control
4. Isolation of N-nitrosodimethylamine from drug substances using solid-phase extraction-liquid chromatography–tandem mass spectrometry
5. Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies
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