Review of the article „Synthesis and characterization of potential and degraded impurities of Regadenoson“, verified by Publons, Web of Science
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Abstract: Background: Regadenoson is an A2A adenosine receptor agonist that is a coronary vasodilator and commonly used as a pharmacologic cardiac stressing agents.
Method: HPLC method was used for related substances analysis. The degraded impurities during the process were isolated and characterized by IR, Mass and NMR spectral analysis.
Result: Forced degradation study of regadenoson under conditions of hydrolysis (neutral, acidic and alkaline) and oxidations suggested in the ICH Q1A(R2) was accomplished. The drug showed significant degradation under all the above conditions. On the whole, five novel degradation products were found under diverse conditions along with process related impurities which are not reported earlier.
Conclusion: All the degradation products were well characterized by using advanced spectroscopic analysis like IR, 1H NMR, 13C NMR and Mass. The identification of these impurities will be productive for the quality control during the production and stability ...behavior of the regadenoson drug substance. Based on the study, regadenoson is sensitive towards acidic, basic and photolytic conditions.
Izvor:
Current Pharmaceutical Analysis, 2019, 1/BMS-CPA-2019-35-20Kolekcije
Institucija/grupa
Mašinski fakultetTY - JOUR AU - Jovanović, Tamara PY - 2019 UR - https://machinery.mas.bg.ac.rs/handle/123456789/5898 AB - Abstract: Background: Regadenoson is an A2A adenosine receptor agonist that is a coronary vasodilator and commonly used as a pharmacologic cardiac stressing agents. Method: HPLC method was used for related substances analysis. The degraded impurities during the process were isolated and characterized by IR, Mass and NMR spectral analysis. Result: Forced degradation study of regadenoson under conditions of hydrolysis (neutral, acidic and alkaline) and oxidations suggested in the ICH Q1A(R2) was accomplished. The drug showed significant degradation under all the above conditions. On the whole, five novel degradation products were found under diverse conditions along with process related impurities which are not reported earlier. Conclusion: All the degradation products were well characterized by using advanced spectroscopic analysis like IR, 1H NMR, 13C NMR and Mass. The identification of these impurities will be productive for the quality control during the production and stability behavior of the regadenoson drug substance. Based on the study, regadenoson is sensitive towards acidic, basic and photolytic conditions. T2 - Current Pharmaceutical Analysis T1 - Review of the article „Synthesis and characterization of potential and degraded impurities of Regadenoson“, verified by Publons, Web of Science EP - 20 SP - 1/BMS-CPA-2019-35 UR - https://hdl.handle.net/21.15107/rcub_machinery_5898 ER -
@article{ author = "Jovanović, Tamara", year = "2019", abstract = "Abstract: Background: Regadenoson is an A2A adenosine receptor agonist that is a coronary vasodilator and commonly used as a pharmacologic cardiac stressing agents. Method: HPLC method was used for related substances analysis. The degraded impurities during the process were isolated and characterized by IR, Mass and NMR spectral analysis. Result: Forced degradation study of regadenoson under conditions of hydrolysis (neutral, acidic and alkaline) and oxidations suggested in the ICH Q1A(R2) was accomplished. The drug showed significant degradation under all the above conditions. On the whole, five novel degradation products were found under diverse conditions along with process related impurities which are not reported earlier. Conclusion: All the degradation products were well characterized by using advanced spectroscopic analysis like IR, 1H NMR, 13C NMR and Mass. The identification of these impurities will be productive for the quality control during the production and stability behavior of the regadenoson drug substance. Based on the study, regadenoson is sensitive towards acidic, basic and photolytic conditions.", journal = "Current Pharmaceutical Analysis", title = "Review of the article „Synthesis and characterization of potential and degraded impurities of Regadenoson“, verified by Publons, Web of Science", pages = "20-1/BMS-CPA-2019-35", url = "https://hdl.handle.net/21.15107/rcub_machinery_5898" }
Jovanović, T.. (2019). Review of the article „Synthesis and characterization of potential and degraded impurities of Regadenoson“, verified by Publons, Web of Science. in Current Pharmaceutical Analysis, 1/BMS-CPA-2019-35-20. https://hdl.handle.net/21.15107/rcub_machinery_5898
Jovanović T. Review of the article „Synthesis and characterization of potential and degraded impurities of Regadenoson“, verified by Publons, Web of Science. in Current Pharmaceutical Analysis. 2019;:1/BMS-CPA-2019-35-20. https://hdl.handle.net/21.15107/rcub_machinery_5898 .
Jovanović, Tamara, "Review of the article „Synthesis and characterization of potential and degraded impurities of Regadenoson“, verified by Publons, Web of Science" in Current Pharmaceutical Analysis (2019):1/BMS-CPA-2019-35-20, https://hdl.handle.net/21.15107/rcub_machinery_5898 .