Development of a Method for Determining the Amino Acid Composition of the Pharmaceutical Substance “Glatiramer Acetate” by NMR Spectroscopy
- Authors: Krylov V.I.1, Kutin A.A.1, Yashkir V.A.1, Merkulov V.A.1, Kuz’mina N.E.1, Moiseev S.V.1
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Affiliations:
- National Center for Expert Assessment of Medicines, “Russian Ministry of Health”
- Issue: Vol 51, No 3 (2017)
- Pages: 226-229
- Section: Article
- URL: https://journals.rcsi.science/0091-150X/article/view/244543
- DOI: https://doi.org/10.1007/s11094-017-1587-2
- ID: 244543
Cite item
Abstract
The acid hydrolysis procedure for glatiramer acetate was modified and the characteristic signals in the 1H and 13C spectra were identified, allowing its amino acid composition to be determined. The relative molar contents of amino acids in glatiramer acetate measured by HPLC-MS and by 13C and 1H NMR had close values. 13C NMR was found to be a more precise method for assaying the amino acid composition of glatiramer acetate than 1H NMR.
About the authors
V. I. Krylov
National Center for Expert Assessment of Medicines, “Russian Ministry of Health”
Email: chem@folium.ru
Russian Federation, 8 Petrovskii Boulevard, Moscow, 127051
A. A. Kutin
National Center for Expert Assessment of Medicines, “Russian Ministry of Health”
Email: chem@folium.ru
Russian Federation, 8 Petrovskii Boulevard, Moscow, 127051
V. A. Yashkir
National Center for Expert Assessment of Medicines, “Russian Ministry of Health”
Email: chem@folium.ru
Russian Federation, 8 Petrovskii Boulevard, Moscow, 127051
V. A. Merkulov
National Center for Expert Assessment of Medicines, “Russian Ministry of Health”
Email: chem@folium.ru
Russian Federation, 8 Petrovskii Boulevard, Moscow, 127051
N. E. Kuz’mina
National Center for Expert Assessment of Medicines, “Russian Ministry of Health”
Email: chem@folium.ru
Russian Federation, 8 Petrovskii Boulevard, Moscow, 127051
S. V. Moiseev
National Center for Expert Assessment of Medicines, “Russian Ministry of Health”
Email: chem@folium.ru
Russian Federation, 8 Petrovskii Boulevard, Moscow, 127051