Five impurities in posaconazole: detection, genotoxicity prediction and action-mechanism analysis

References

• Giordani, A., Kobel, W., Gally, H.U. (2011). Overall impact of the regulatory requirements for genotoxic impurities on the drug development process. European Journal of Pharmaceutical Sciences. 43(1): 1-15. doi: 10.1016/j.ejps.2011.03.004
   PubMed Web of Science ®Google Scholar
• Szekely, G., Amorea De Sousa, M.C., Gil, M., Castelo Ferreira, F., Heggie, W. (2015). Genotoxic Impurities in Pharmaceutical Manu-facturing: Sources, Regulations, and Mitigation. Chemical Reviews. 115(16): 8182-8189. doi: 10.1021/cr300095f
   PubMed Web of Science ®Google Scholar
• ICH. (2012). Harmonised Tripartite Guideline. S2(R1) Genotoxicity Testing and Data Inter-pretation for Pharmaceuticals Intended for Human Use.
   Google Scholar
• Liu, D.Q., Sun, M., Kord, A.S. (2010). Recent advances in trace analysis of pharmaceutical genotoxic impurities. Journal of Pharmaceutical and Biomedical Analysis. 51(5): 999-1014. doi: 10.1016/j.jpba.2009.11.009
   PubMed Web of Science ®Google Scholar
• Maithani, M., Raturi, R., Gupta, V., Bansal, P. (2017). Evolution of regulatory aspects of genotoxic impurities in pharmaceuticals: Survival of the fittest. Journal of Liquid Chromatography & Related Technologies. 40(15): 759-769. doi: 10.1080/10826076.2017.1357574
   Web of Science ®Google Scholar
• Raman, N.V.V.S.S., Prasad, A.V.S.S. (2011). Ratnakar Reddy K. Strategies for the identi-fication, control and determination of genotoxic impurities in drug substances: A pharmaceutical industry perspective. Journal of Pharmaceutical and Biomedical Analysis. 55(4): 662-667. doi: 10.1016/j.jpba.2010.11.039
   PubMed Web of Science ®Google Scholar
• McGovern, T., Jacobson-Kram, D. (2006). Regulation of genotoxic and carcinogenic impurities in drug substances and products. Trac-trends In Analytical Chemistry. 25(8): 790-795. doi: 10.1016/j.trac.2006.06.004
   Web of Science ®Google Scholar
• FDA. (2008). Guidance for industry: genotoxic and carcinogenic impurities in drug substances and products: recommended approaches (draft), December.
   Google Scholar
• ICH. (2017). M7(R1) Addendum to ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. London: European Medicines Agency.
   Google Scholar
• Tejaswini, K., Srijita, S., Sayalee, S.M., Gopal, D.B., Swapnil, J.D. (2023). Om Prakash Ranjan, Development of posaconazole nanosuspension for bioavailability enhancement: Formulation optimization, in vitro characterization and phar-macokinetic study, Journal of Drug Delivery Science and Technology. 83: 104434. doi: 10.1016/j.jddst.2023.104434
   Web of Science ®Google Scholar
• Wei, X.C., Zhao, M.F., Xiao, X. (2024). Supratherapeutic posaconazole concentrations associated with hyperlipidemia in a patient with HSCT, Journal of Infection and Chemotherapy. 30: 255-257. doi: 10.1016/j.jiac.2023.10.008
   PubMed Web of Science ®Google Scholar
• Yang, S., Zhang, X., Wang, Y., Wen, C., Wang, C., Zhou, Z., Lin, G. (2021). Development of UPLC-MS/MS Method for Studying the Pharmacokinetic Interaction Between Dasatinib and Posaconazole in Rats, Drug Design, Development and Therapy. 15: 2171-2178. doi: 10.2147/DDDT.S301241
   PubMed Web of Science ®Google Scholar
• Liu, D., Peng, X.X., Fang, J.M., et al. (2024). Detection of 14 sulfonate esters impurities of active pharmaceutical ingredients from based on GC-MS/MS and LC-MS/MS. Acta Pharmaceutica Sinica. 59(02): 424-431.
   Google Scholar
• ICH. (2005). Q2(R1) Validation of Analytical Procedures: Text and Methodology Guidance for Industry, November.
   Google Scholar
• Benigni, R., Bossa, C. (2011). Mechanisms of Chemical Carcinogenicity and Mutagenicity: A Review with Implications for Predictive Toxicology. Chemical Reviews. 111(4): 2507-2536. doi: 10.1021/cr100222q
   PubMed Web of Science ®Google Scholar
• Eder, E., Kütt, W., Deininger, C. (2001). On the role of alkylating mechanisms, O-alkylation and DNA-repair in genotoxicity and mutagenicity of alkylating methanesulfonates of widely varying structures in bacterial systems. Chemico-Biological Interactions. 137(1): 89-99. doi: 10.1016/S0009-2797(01)00211-3
   PubMed Web of Science ®Google Scholar
• Gamberini, M., Cidade, M.R., Valotta, L.A., Armelin, M.C., Leite, L.C. (1998). Contribution of hydrazines-derived alkyl radicals to cytotoxicity and transformation induced in normal c-myc-overexpressing mouse fibroblasts. Carcinogenesis. 19(1): 147-155. doi: 10.1093/carcin/19.1.147
   PubMed Web of Science ®Google Scholar
• Kovacic, P.J.J. (2001). Mechanisms of carcinogenesis: focus on oxidative stress and electron transfer. Current Medicinal Chemistry. 8(7): 773. doi: 10.2174/0929867013373084
   PubMed Web of Science ®Google Scholar
• Gannett, P.M., Shi, X., Lawson, T., Kolar, C., Toth, B. (1997). Aryl radical formation during the metabolism of arylhydrazines by microsomes. Chemical Research In Toxicology. 10(12): 1372-1377. doi: 10.1021/tx970084y
   PubMed Web of Science ®Google Scholar
• Nelson, S.D. (1982). Metabolic activation and drug toxicity. Journal of Medicinal Chemistry. 25(7): 753-765. doi: 10.1021/jm00349a001
   PubMed Web of Science ®Google Scholar