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Methodological approaches to the choice of identification test methods for medicines

Abstract

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.

About the Authors

A. I. Lutseva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation


T. N. Bokovikova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation


V. A. Yashkir
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation


L. A. Stronova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation


N. E. Kuzmina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation


M. V. Agapkina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation


L. I. Panova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation


E. N. Popova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation


N. V. Gadasina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation


L. N. Bulanova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation


V. I. Prokofieva
I. M. Sechenov First Moscow State Medical University
Russian Federation


References

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Review

For citations:


Lutseva A.I., Bokovikova T.N., Yashkir V.A., Stronova L.A., Kuzmina N.E., Agapkina M.V., Panova L.I., Popova E.N., Gadasina N.V., Bulanova L.N., Prokofieva V.I. Methodological approaches to the choice of identification test methods for medicines. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2017;7(2):71-76. (In Russ.)

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ISSN 3034-3062 (Print)
ISSN 3034-3453 (Online)