Method Validation for Anticomplementary Activity of Human Immunoglobulin Drugs

M. A. Krivykh; O. G. Kornilova; N. D. Bunyatyan; E. V. Paramonova; R. A. Volkova; O. V. Fadeikina

doi:10.1007/s11094-016-1503-1

Method Validation for Anticomplementary Activity of Human Immunoglobulin Drugs

Autores: Krivykh M.¹, Kornilova O.¹, Bunyatyan N.¹, Paramonova E.¹, Volkova R.¹, Fadeikina O.¹
Afiliações:
1. State Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Edição: Volume 50, Nº 9 (2016)
Páginas: 625-629
Seção: Article
URL: https://journals.rcsi.science/0091-150X/article/view/244450
DOI: https://doi.org/10.1007/s11094-016-1503-1
ID: 244450

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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.