Development of the method of trifluoroacetates determination in glatiramer acetate pharmaceutical substance by19F NMR spectroscopy
Abstract
The article describes a newly developed procedure of quantitative determination of fluorine which is present in residual trifluoroacetates in glatiramer acetate pharmaceutical substances by19F NMR spectroscopy. Test parameters (the relaxation delay and the number of scans) were selected to minimize errors in quantitative measurements. Comparative analysis of available water-soluble fluorine-containing compounds showed that trifluoroethanol could be reasonably used as an internal standard for the determination of the absolute content of trifluoroacetic acid residues in glatiramer acetate. It was demonstrated that the new method could be used for quantitative determination of trifluoroacetates with no need for a series of reference standards and without destruction of glatiramer acetate.
About the Authors
S. V. Moiseev
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
V. I. Krylov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
N. E. Kuz’Mina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
V. A. Yashkir
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
V. A. Merkulov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
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Review
For citations:
Moiseev S.V., Krylov V.I., Kuz’Mina N.E., Yashkir V.A., Merkulov V.A. Development of the method of trifluoroacetates determination in glatiramer acetate pharmaceutical substance by19F NMR spectroscopy. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2017;7(4):256-260. (In Russ.)
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