Uncertainty Analysis of IgAResidue in Human Immunoglobulin(pH 4)for Intravenous Injection
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 1 nm 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.
Human immunoglobulin(pH 4)for intravenous injectionIgA residueUncertaintyUV-vis spectrophotometry
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