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Research progress on the impurities identification and determination in pharmaceuticals
  • +2
  • wenlong Li,
  • Yuru Chen,
  • Zhiyong Zhang,
  • Xin Gao,
  • Xuting Guo
wenlong Li
Tianjin University of Traditional Chinese Medicine

Corresponding Author:[email protected]

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Yuru Chen
Tianjin University of Traditional Chinese Medicine
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Zhiyong Zhang
Tianjin University of Traditional Chinese Medicine
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Xin Gao
Tianjin University of Traditional Chinese Medicine
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Xuting Guo
Tianjin University of Traditional Chinese Medicine
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Abstract

Rationale: Impurities refer to any substances that affect the purity of pharmaceuticals. Controlling impurities has always been a significant concern during drug development. Impurities impact the drug’s purity, diminish the efficacy of pharmaceuticals, and alter their appearance, physical, and chemical properties. Additionally, impurities can compromise the stability of pharmaceuticals and elevate their toxic and side effects. Methods: Impurity source analysis is the basis of drug impurity control. To clarify the source of impurity can optimize the synthesis process, prescription process, packaging and storage conditions of the pharmaceuticals, and control the impurity within a reasonable limit to achieve the ultimate goal of impurity research. Results: Analysis method is a means to obtain impurity information, and diversified analysis methods are also possible for effective control of different types of impurities. At present, there are relatively many quantitative studies on impurities, but there are still some challenges for the structure analysis of impurities, especially trace impurities. Conclusion: The research progress of drug impurity control and evaluation from the sources of various drug impurities and impurity analysis techniques was reviewed in this article, with the aim of providing references for the related research.
10 Jul 2023Submitted to Rapid Communications in Mass Spectrometry
10 Jul 2023Assigned to Editor
10 Jul 2023Submission Checks Completed
10 Jul 2023Review(s) Completed, Editorial Evaluation Pending
10 Jul 2023Reviewer(s) Assigned