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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.

The study was carried out on 111 series of human immunoglobulin preparations (81 series for intravenous use, 30 series for intramuscular use) produced abroad and in Poland. Kallikrein (KK) and prekallikrein activator (PKA) activities were identified using chromogenic substrate. S-2302 and proteinase inhibitors were tested by double immunodiffusion method. Several biochemical, biological and serological methods were also applied which are valid in the control of intravenous and intramuscular immunoglobulin preparations. It was found that trace amounts of PKA and KK are present in human immunoglobulin preparations for intravenous use such as Bioglobulina and Gamma-Venina (PKA 0.0092-0.0505 mu kat/L, and KK 0,-0.0093 mu kat/L). On the other hand normal human immunoglobulin preparations for intramuscular use had somewhat higher level of KK and PKA and anti-HBs Immunoglobulin preparations (5.50 mu kat/L and 153.91 mu kat/L) and Tetabulina preparations had very high levels of these factors as compared to remaining preparations (4.50 mu kat/L and 316.5 mu kat/L).