Abstract
Composition uniformity and formula reproducibility of the dry type granu-lated dialysate, AKDD, Town Pharm., were evaluated, in comparison with those of the control, AF-2, a liquid type dialysate concentrate. Both of these dialysates are of glucose-added bicarbonate type. Samples were taken according to a statistical experimental nested design. Three bags were extracted from each of three lots (3×3) and five 1.0 gram samples were randomly taken from each of bags: 45 samples were used in total for this study. Na and K were determined by the flame photometry, Ca by the OCPC method, Mg by the xylidyl-blue method and the flame atomic absorption spectrometry and glucose by the enzyme method respectively, The results confi-rmed the uniformity of all observed components of AKDD with less than 2.0% of C.V.s (coefficient of variance), which were equivalent to those obtained with AF-2. The result also conformed to the uniformity test standard of the Japanese Pharmacopoeia XI. Error in the formulation reproducibility was 0.6% for Na, 3.5% for K, 4.7% for Ca, 1.3% for Mg and 1.6% for glucose respe-ctively.
