抄録
Concentrations of sodium (Na) and potassium (K), and osmolality (OSM) of 6 human serum albumin (HSA) injections obtained from each pharmaceutical manufacturer were determined. The concentrations of Na and K were determined by atomic absorption spectrometry, and OSM was analyzed with freezing point method.The reproducibilities of Na, K and OSM determinations were about 2, 4 and 2%, respectively.
The determined data were compared with each value informed from 6 manufacturers.In Na concentrations of all HSA injections, there were no significant differences between the data and indicated ones on the packages (p<0.01).However, coefficient of variation (CV) value of 3 lots in one product was 13%.The concentrations of K determined in 4 products were different from those informed from each manufacturer;furthermore the CV values of 5 products were more than 19%.The CV values of OSM of 4 products were less than 5%, but those of 2 products were 13 and 16%, respectively.The ratios of OSM of 2 HSA injections to normal saline were less than indicated values on each package inserts.
