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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Notes
Mp is the peak MW on measurement of mean MW. Mw is the weight average MW of the polymer. Mn is the number average MW of the polymer.
Ds is the mean self-diffusion coefficient. Dp is the peak self-diffusion coefficient on the distribution plot.
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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 51, No. 9, pp. 60 – 63, September, 2017.
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Moiseev, S.V., Kuz’mina, N.E., Krylov, V.I. et al. Validation of a Method of Measuring Mean Molecular Weight of Dextrans by Diffusion-Ordered Spectroscopy. Pharm Chem J 51, 829–832 (2017). https://doi.org/10.1007/s11094-017-1701-5
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DOI: https://doi.org/10.1007/s11094-017-1701-5