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

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 c...

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Bibliographic Details
Published inPharmaceutical chemistry journal Vol. 50; no. 5; pp. 328 - 330
Main Authors Krivykh, M. A., Kornilova, O. G., Bunyatyan, N. D., Kudasheva, E. Yu
Format Journal Article
LanguageEnglish
Published New York Springer US 01.08.2016
Springer
Subjects
Immunoglobulins
Medicine
Organic Chemistry
Pharmacology/Toxicology
Pharmacy
human immunoglobulin
pharmacopoeia
anticomplementary activity
harmonization
standard sample
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Summary: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.
ISSN:0091-150X
1573-9031
DOI:10.1007/s11094-016-1446-6