Certification of Human Immunoglobulin Standard Samples for Determination of Anticomplementary Activity


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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.

作者简介

M. Krivykh

Scientific Center for Expert Evaluation of Medicinal Products (SCEEMP), Ministry of Public Health of the Russian Federation

Email: chem@folium.ru
俄罗斯联邦, Moscow, 127051

O. Kornilova

Scientific Center for Expert Evaluation of Medicinal Products (SCEEMP), Ministry of Public Health of the Russian Federation

Email: chem@folium.ru
俄罗斯联邦, Moscow, 127051

N. Bunyatyan

Scientific Center for Expert Evaluation of Medicinal Products (SCEEMP), Ministry of Public Health of the Russian Federation

Email: chem@folium.ru
俄罗斯联邦, Moscow, 127051

E. Paramonova

Scientific Center for Expert Evaluation of Medicinal Products (SCEEMP), Ministry of Public Health of the Russian Federation

Email: chem@folium.ru
俄罗斯联邦, Moscow, 127051

É. Kudasheva

Scientific Center for Expert Evaluation of Medicinal Products (SCEEMP), Ministry of Public Health of the Russian Federation

Email: chem@folium.ru
俄罗斯联邦, Moscow, 127051

E. Novikova

Scientific Center for Expert Evaluation of Medicinal Products (SCEEMP), Ministry of Public Health of the Russian Federation

Email: chem@folium.ru
俄罗斯联邦, Moscow, 127051

O. Ustinnikova

Scientific Center for Expert Evaluation of Medicinal Products (SCEEMP), Ministry of Public Health of the Russian Federation

Email: chem@folium.ru
俄罗斯联邦, Moscow, 127051

R. Volkova

Scientific Center for Expert Evaluation of Medicinal Products (SCEEMP), Ministry of Public Health of the Russian Federation

Email: chem@folium.ru
俄罗斯联邦, Moscow, 127051

O. Fadeikina

Scientific Center for Expert Evaluation of Medicinal Products (SCEEMP), Ministry of Public Health of the Russian Federation

Email: chem@folium.ru
俄罗斯联邦, Moscow, 127051

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