Development of a Method for Determining the Amino Acid Composition of the Pharmaceutical Substance “Glatiramer Acetate” by NMR Spectroscopy


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Аннотация

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.

Авторлар туралы

V. Krylov

National Center for Expert Assessment of Medicines, “Russian Ministry of Health”

Email: chem@folium.ru
Ресей, 8 Petrovskii Boulevard, Moscow, 127051

A. Kutin

National Center for Expert Assessment of Medicines, “Russian Ministry of Health”

Email: chem@folium.ru
Ресей, 8 Petrovskii Boulevard, Moscow, 127051

V. Yashkir

National Center for Expert Assessment of Medicines, “Russian Ministry of Health”

Email: chem@folium.ru
Ресей, 8 Petrovskii Boulevard, Moscow, 127051

V. Merkulov

National Center for Expert Assessment of Medicines, “Russian Ministry of Health”

Email: chem@folium.ru
Ресей, 8 Petrovskii Boulevard, Moscow, 127051

N. Kuz’mina

National Center for Expert Assessment of Medicines, “Russian Ministry of Health”

Email: chem@folium.ru
Ресей, 8 Petrovskii Boulevard, Moscow, 127051

S. Moiseev

National Center for Expert Assessment of Medicines, “Russian Ministry of Health”

Email: chem@folium.ru
Ресей, 8 Petrovskii Boulevard, Moscow, 127051

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