[Studies on the quality of enzyme preparations (XII)--lysozyme preparations]

This paper was described the results of the weight variation test and the assay for the potency of the commercially available lysozyme preparations (samples: 13 kinds of granules, in which 10 kinds are granules (folded)) collected for the legal sampling inspection in 1992. The potencies of 10 samples were found to be within the range of permissible content, when the all samples extracted with phosphate buffer were determined by the method described in Japanese Standards of Pharmaceutical Ingredients. However, the potencies of 3 samples were not more than 65% of the labeled potencies. These low potency samples showed the potencies of 98-106%, when 0.4M sodium chloride solution or 0.1N hydrochloric acid was used instead of phosphate buffer for enzyme extraction. The weight variation test showed all preparations to be within the permissible JP XII deviation range (10%) for "granules (folded)".