Five impurities in posaconazole: detection, genotoxicity prediction and action-mechanism analysis
Author:
Affiliation:
1. Drug research and development center, Jiangxi Kerui Pharmaceutical Co., LTD. Ganzhou, Jiangxi 341000, P.R. China
Funder
Central Guiding Local Science and Technology Development Fund Projects
the Ganpo Juncai Support Program-Training Program for Academic and Technical Leaders in Major Disciplines
Publisher
Informa UK Limited
Link
https://www.tandfonline.com/doi/pdf/10.1080/22297928.2024.2343935
Reference20 articles.
1. Overall impact of the regulatory requirements for genotoxic impurities on the drug development process
2. Genotoxic Impurities in Pharmaceutical Manufacturing: Sources, Regulations, and Mitigation
3. ICH. (2012). Harmonised Tripartite Guideline. S2(R1) Genotoxicity Testing and Data Inter-pretation for Pharmaceuticals Intended for Human Use.
4. Recent advances in trace analysis of pharmaceutical genotoxic impurities
5. Evolution of regulatory aspects of genotoxic impurities in pharmaceuticals: Survival of the fittest
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