Identifying the Risk of Formation of Nitrosamines and Other Potentially Mutagenic Impurities during API Manufacture Using <i>In Silico</i> Risk Assessment-Reference-Cited by-同舟云学术

Identifying the Risk of Formation of Nitrosamines and Other Potentially Mutagenic Impurities during API Manufacture Using In Silico Risk Assessment

Published:2023-06-06 Issue:10 Volume:27 Page:1812-1819
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Murphy Natasha S.¹,O’Connor Daniel C.¹,Gavins Georgina C.¹,James Lara¹,Lockett Jonathan P.¹,McManus James A.¹^ORCID,Packer Gemma¹,Lopez-Rodríguez Rocío¹,Webb Samuel J.¹^ORCID,Burns Michael J.¹^ORCID

Affiliation:

1. Lhasa Limited, Leeds LS11 5PS, West Yorkshire, U.K.

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.3c00118

Reference38 articles.

1. Risk assessment report of potential impurities in cetirizine dihydrochloride

2. Pathways for N-Nitroso Compound Formation: Secondary Amines and Beyond

3. Strategies for the Evaluation of Genotoxic Impurity Risk

4. A Tool for the Semiquantitative Assessment of Potentially Genotoxic Impurity (PGI) Carryover into API Using Physicochemical Parameters and Process Conditions

Cited by 8 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Nitrosamine contamination of pharmaceuticals: Cases in Japan, formation mechanisms, detection methods, regulatory perspectives, and insights;Journal of Pharmaceutical and Biomedical Analysis Open;2024-12

2. NAVIGATING NITROSAMINES: ORIGIN, DETECTING, ANALYSING AND REGULATING IMPURITIES IN PHARMACEUTICALS;International Journal of Applied Pharmaceutics;2024-09-07

3. On the role of digital tools in nitrosamine risk assessment for drug substance and drug product manufacturing processes;Current Opinion in Chemical Engineering;2024-09

4. Analytical Methodologies to Detect N-Nitrosamine Impurities in Active Pharmaceutical Ingredients, Drug Products and Other Matrices;Chemical Research in Toxicology;2024-08-19

5. Faster Development of the Crystallization Process Thanks to Process Analytical Technologies;Chemické listy;2024-06-15