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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Bibliografische gegevens

Hoofdauteurs:	N. E. Kuz’Mina, S. V. Moiseev, V. I. Krylov, A. A. Kutin, E. A. Zhukov, V. A. Yashkir, V. A. Merkulov
Formaat:	Artigo
Taal:	Russo
Gepubliceerd in:	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
Reeks:	Регуляторные исследования и экспертиза лекарственных средств
Onderwerpen:	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 toegang:	https://www.vedomostincesmp.ru/jour/article/view/138
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