Регуляторные исследования и экспертиза лекарственных средств (Feb 2018)

Methodological approaches to the choice of identification test methods for medicines

  • A. I. Lutseva,
  • T. N. Bokovikova,
  • V. A. Yashkir,
  • L. A. Stronova,
  • N. E. Kuzmina,
  • M. V. Agapkina,
  • L. I. Panova,
  • E. N. Popova,
  • N. V. Gadasina,
  • L. N. Bulanova,
  • V. I. Prokofieva

Journal volume & issue
Vol. 7, no. 2
pp. 71 – 76

Abstract

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The article summarises the main selective and non-selective methods of physical, chemical and physico-chemical analysis which are used in medicines identification testing and which differ in selectivity, sensitivity, informative value, sample preparation, and availability. The article demonstrates that the choice of methods is governed by chemical, physical and physico-chemical properties of medicines and the type of medicine (whether it is a substance or a finished dosage form). The article describes a complex approach based on the use of several analytical methods, the cumulative results of which are used to support medicines identification.

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