Research progress on the impurities identification and
determination in pharmaceuticals
Yuru Chena#, Zhiyong Zhanga#, Xin
Gaoa, Xuting Guoa, Wenlong
Lia, b, c11* Corresponding
author. Tel.: +86 22 59596814; Fax: +86 22 59596814.E-mail address:
wshlwl@tjutcm.edu.cn (W. Li).
a College of Pharmaceutical Engineering of Traditional
Chinese Medicine, Tianjin University of Traditional Chinese Medicine,
Tianjin, 301617, PRC;
b State key Laboratory of Component-based Chinese
Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin,
301617, PRC;
c Haihe Laboratory of Modern Chinese Medicine,
Tianjin, 301617, PRC
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.
Keywords: Impurities in pharmaceuticals; Impurity source
identification; Separation and purification techniques; Qualitative and
quantitative methods