Research progress on the impurities identification and determination in
pharmaceuticals
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.