Validation of the procedure for determination of amino acids composition of glatiramer acetate by C-13 NMR spectroscopy

Validation of the procedure for determination of amino acids composition of glatiramer acetate by C-13 NMR spectroscopy

The article describes validation of the procedure for determination of amino acids composition of glatiramer acetate by C-13 NMR spectroscopy. The procedure makes it possible to determine the molar ratio of amino acids present in glatiramer acetate with no need for a reference standard. The authors...

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Bibliographic Details
Main Authors: N. E. Kuz’Mina, S. V. Moiseev, V. I. Krylov, A. A. Kutin, E. A. Zhukov, V. A. Yashkir, V. A. Merkulov
Format: Article
Language:Russian
Published: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2018-02-01
Series:Регуляторные исследования и экспертиза лекарственных средств
Subjects:
глатирамера ацетат
метод<sup>13</sup>c ямр-спектроскопии
аминокислотный состав
валидация аналитической методики
линейность
правильность
сходимость
прецизионность
glatiramer acetate
c-13 nmr spectroscopy
amino acids composition
analytical procedure validation
linearity
accuracy
repeatability
precision
Online Access:https://www.vedomostincesmp.ru/jour/article/view/138
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