关键词: font-size:medium, ">静注人免疫球蛋白；IgA残留量；不确定度；紫外可见分光光度法

Abstract: Objective： To determine the residual amount of IgA in human immunoglobulin (pH 4) for intravenous injection by UV-VIS spectrophotometry and evaluate its uncertainty. Methods： Ultraviolet-visible spectrophotometry was used to measure the wavelength with 1nm slit colorimetric dish. Each component was evaluated according to the operation process and the influencing factors introduced in the determination process. Results： The IgA residue in human immunoglobulin (pH 4) for intravenous injection was 103 μg·mL-1， with an expanded uncertainty of 10 μg·mL-1 (k=2) .Conclusion： This research firstly evaluated and analyzed the uncertainty component of IgA residue in human immunoglobulin (pH 4) for intravenous injection， which provided a source analysis of influencing factors for blood products inspection and data analysis to improve the accuracy of test results.

Key words: font-size:medium, ">Human immunoglobulin (pH 4) for intravenous injection； IgA residue； Uncertainty； UV-vis spectrophotometry