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- W4283265420 abstract "The solution properties of hydroxyethyl starch (HES) vary significantly owing to different measurement parameters adopted and sample structures. Here, a round-robin study was conducted to compare inter-laboratory measurements of solution properties, weight-average molecular weight (Mw), and molecular weight distribution of four HES candidates covering the low- and medium-molecular-weight range, and 50 commercially available HES 130/0.4 drug samples. Analysis was performed using size exclusion chromatography (SEC) combined with multi-angle laser light scattering (MALLS) and differential refractive index (dRI) detectors. The results indicate that HES molecules in the Mw range of 17,000-130,000, with varying degrees of substitution (between 0.4 and 0.8), yielded a refractive index increment (dn/dc) value of 0.145 ± 0.003 mL/g (solvent: acetic acid-sodium acetate buffer; wavelength: 658 nm) and that the second virial coefficient (A2) is correlated with Mw. The SEC-MALLS-dRI method for Mw determination of HES demonstrated good inter-laboratory reproducibility; however, the study findings suggest that column specifications should be added for HES quality standards. Comparing Mw results obtained using common and experimentally corrected dn/dc and A2 values revealed an influence of dn/dc and A2 on Mw, indicating that the Mw acceptance criteria of HES quality standards should be adjusted." @default.
- W4283265420 created "2022-06-23" @default.
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- W4283265420 date "2022-09-01" @default.
- W4283265420 modified "2023-10-14" @default.
- W4283265420 title "Measurement of solution properties and molecular weight of hydroxyethyl starches using multi-angle laser light scattering: An interlaboratory comparison" @default.
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- W4283265420 doi "https://doi.org/10.1016/j.jpba.2022.114905" @default.
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