Method Validation for Anticomplementary Activity of Human Immunoglobulin Drugs
- Authors: Krivykh M.A.1, Kornilova O.G.1, Bunyatyan N.D.1, Paramonova E.V.1, Volkova R.A.1, Fadeikina O.V.1
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Affiliations:
- State Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
- Issue: Vol 50, No 9 (2016)
- Pages: 625-629
- Section: Article
- URL: https://journals.rcsi.science/0091-150X/article/view/244450
- DOI: https://doi.org/10.1007/s11094-016-1503-1
- ID: 244450
Cite item
Abstract
Amethod for determining anticomplementary activity of human immunoglobulin (Ig) preparations for i.v. administration by complement fixation test was validated for accuracy, precision (repeatability, intralaboratory precision), limit of quantitation (LOQ), linearity, and analytical domain. The method could be used for quality assessment using the “anticomplementary activity” as part of the pharmaceutical quality examination of human Ig preparations.
About the authors
M. A. Krivykh
State Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: chem@folium.ru
Russian Federation, Moscow, 127051
O. G. Kornilova
State Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: chem@folium.ru
Russian Federation, Moscow, 127051
N. D. Bunyatyan
State Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: chem@folium.ru
Russian Federation, Moscow, 127051
E. V. Paramonova
State Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: chem@folium.ru
Russian Federation, Moscow, 127051
R. A. Volkova
State Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: chem@folium.ru
Russian Federation, Moscow, 127051
O. V. Fadeikina
State Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: chem@folium.ru
Russian Federation, Moscow, 127051