Development of Pharmacopoeial Methods for Determining the Anticomplementary Activity of Human Immunoglobulin Preparations

被引：0
|
作者：
Krivykh, M. A. [1 ]
Kornilova, O. G. [1 ]
Bunyatyan, N. D. [1 ]
Kudasheva, E. Yu. [1 ]
机构：
[1] Minist Publ Hlth Russian Federat, Sci Ctr Expert Evaluat Med Prod, Moscow 127051, Russia
来源：
PHARMACEUTICAL CHEMISTRY JOURNAL | 2016年 / 50卷 / 05期
关键词：
pharmacopoeia; harmonization; anticomplementary activity; human immunoglobulin; standard sample;
D O I：
10.1007/s11094-016-1446-6
中图分类号：
R914 [药物化学];
学科分类号：
100701 ;
摘要：
The development of a pharmacopoeial method for determining the anticomplementary activity of human immunoglobulin preparations was reviewed. It was shown that the methods for determining anticomplementary activity that are used by domestic manufacturers of human immunoglobulin preparations did not comply with current international requirements, primarily because a standard sample was not used. The general pharmacopoeial monograph "Determination of anticomplementary activity of human immunoglobulin preparations for intravenous administration" that was published in the Russian Federation State Pharmacopoeia, XIIIth Edition, was formulated for the first time as a result of optimizing the conditions for determining anticomplementary activity and harmonization of the method with major foreign pharmacopoeias.
引用
收藏
页码：328 / 330
页数：3
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