Determination of the Humidity of Several Lyophilized Biological Products

Abstract

1) Dried B. C. G. Vaccine and Dried Normal Human Serum are marked as lyophilized product sealed in hermetic ampuls. In such a country as Japan where atmospheric moisture is very high, the moisture content of air in the room where ampuls are opened for examination of moisture content gives a great deal of effect on the determined values. For this reason, the relationship between the moisture content of air and the time spent in weighing was examined. Both preparations were found to absorb approximately 1-5% of moisture during 3 minutes of weighing in the air containing 50% or more moisture. When the relative moisture was below 30%, there were almost no increase in the weight of a sample by weighing during 3 minutes.
2) The moisture content of Dried B. C. G. Vaccine and Dried Serum is carried out by the weight method. Comparison of this method with that using the Karl Fischer reagent (time of contact with the reagent: 45 minutes) showed that both preparations gave a larger value by the Karl Fischer method, but with penicillin and streptomycin, there were no difference between the values by the two methods.