Certification of Human Immunoglobulin Standard Samples for Determination of Anticomplementary Activity

Abstract

An evaluation and stability study of the original Russian human immunoglobulin standard intended for determining the anticomplementary activity and assessing the stability and acceptability of test results are reported. The certified values of the experimental anticomplementary activity of the negative control standard fell in the range 37.9 – 45.1%; of the positive control, 73.6 – 82.8% (for P = 0.95). Ashelf life of 1.5 years was justified based on the stability data of the standard sample. Introduction of the certified reference materials into the analysis of human immunoglobulin pharmaceutical preparation for intravenous administration during evaluation and quality control under government projects and confirmation of compliance with regulatory requirements will ensure that the determined anticomplementary properties are accurate.