Validation of a Method of Measuring Mean Molecular Weight of Dextrans by Diffusion-Ordered Spectroscopy


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Amethod for measuring the mean molecular weight of dextrans by diffusion-ordered NMR spectroscopy was developed and validated. This method allows measurements of dextran self-diffusion coefficients to determine their mean molecular weight. The linearity, correctness, similarity, intralaboratory precision, and specificity of the method were evaluated. “Added/found” ratios for different dextrans were used to determine the standard deviations, coefficients of variation, significance intervals, systematic errors, Fisher’s F test, and Student’s t test for measurements of mean molecular weight. These statistical characteristics satisfied the criteria for validation parameters in the Russian and foreign normative documentation.

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S. Moiseev

Scientific Center for Expert Evaluation of Medical Products, Ministry of Health of the Russian Federation

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Email: MoiseevSV@expmed.ru
俄罗斯联邦, Building 2, 8 Petrovskii Boulevard, Moscow, 127051

N. Kuz’mina

Scientific Center for Expert Evaluation of Medical Products, Ministry of Health of the Russian Federation

Email: MoiseevSV@expmed.ru
俄罗斯联邦, Building 2, 8 Petrovskii Boulevard, Moscow, 127051

V. Krylov

Scientific Center for Expert Evaluation of Medical Products, Ministry of Health of the Russian Federation

Email: MoiseevSV@expmed.ru
俄罗斯联邦, Building 2, 8 Petrovskii Boulevard, Moscow, 127051

V. Yashkir

Scientific Center for Expert Evaluation of Medical Products, Ministry of Health of the Russian Federation

Email: MoiseevSV@expmed.ru
俄罗斯联邦, Building 2, 8 Petrovskii Boulevard, Moscow, 127051

V. Merkulov

Scientific Center for Expert Evaluation of Medical Products, Ministry of Health of the Russian Federation

Email: MoiseevSV@expmed.ru
俄罗斯联邦, Building 2, 8 Petrovskii Boulevard, Moscow, 127051

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