[Human normal immunoglobulin, requirements for its safety and potency (author's transl)].

On the basis of the official requirements for human normal immunoglobulin established by the European Pharmacopoeia, the immunoglobulins for intramuscular and intravenous use are described and analyzed. According to manufacturers processing by enzymatic digestion, chemical or other treatment the immunoglobulins, for intravenous use show differences in their composition, especially in regards to the distribution of aggregates, monomers and fragments of immunoglobulins and their subclass composition as well as their anticomplementary activity. Relative to the antibody content, the majority of the preparations show minor differences, only in an immunoglobulin of placental origin the content of tetanus antibodies was very low.