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

详细

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.