title: Stability of European anti-D immunoglobulin preparations.
abstract: The stability of 18 batches of anti-D immunoglobulin preparations from 7 European manufacturers was studied over 28-day incubation at +37 degrees C and 3-year storage at +4 degrees C. The mean loss of activity after 28 days at +37 degrees C was 12.3 +/- 8.2%, and after 3 years at +4 degrees C 15.2 +/- 9.5%. The correlation coefficient of the loss of activity between these two storages was r = 0.61, p less than 0.05 indicating that short-term incubation can be used to evaluate the shelf life stability of anti-D activity. In general, measurements of IgG fragments or activities of plasmin, plasminogen, or prekallikrein activator were not valuable in predicting the stability of anti-D activity due to the fact that the preparation of each manufacturer has its own unique pattern of enzymes and inhibitors. The anti-D immunoglobulin preparations contained up to at least 7 plasma proteins in addition to IgG. All preparations contained factor B, most of them alpha 2-macroglobulin, alpha 1-antitrypsin, albumin, and alpha 2-HS glycoprotein, alpha-Lysozyme was present in 7, and ceruloplasmin in 2 preparations. Neither purity nor impurity correlated with stability.
authors.affiliation: Finnish Red Cross Blood Transfusion Service, Helsinki.
authors.forename: H
authors.initials: H
authors.lastname: Suomela
mesh_terms: D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D005060:Europe; D015956:Factor XIIa / Q000032:analysis; D005341:Fibrinolysin / Q000032:analysis; D006801:Humans; D007136:Immunoglobulins / Q000737:chemistry* / Q000276:immunology; D007518:Isoantibodies / Q000737:chemistry* / Q000276:immunology; D010958:Plasminogen / Q000032:analysis; D015203:Reproducibility of Results; D012204:Rh-Hr Blood-Group System / Q000276:immunology*; D018029:Rho(D) Immune Globulin
chemical_list: D007136:Immunoglobulins; D007518:Isoantibodies; C061961:RHO(D) antibody; D012204:Rh-Hr Blood-Group System; D018029:Rho(D) Immune Globulin; D010958:Plasminogen; D015956:Factor XIIa; D005341:Fibrinolysin