Compatibility of U-67590A Sterile Solution with Normal Saline, Dextrose Solution, and Solita-T No. 3 with or without Aminophylline Injectable

Abstract

The compatibility of U-67590A sterile solution (SS) with three drip fluids (normal saline, 5% dextrose solution, and Solita-T No. 3) and Neophylline^R (an aminophylline injectable) was studied. The entire volume of U-67590A SS in an ampoule was transferred into each of the drip fluid containers (500 mL fill). The container was laid under fluorescent light (ca. 1,200 lux) at room temperature. The physical appearance (color and precipitates), pH, U-67590A concentration, and degradation impurity levels were examined for 24 hr. The chemical and physical stability of U-67590A in these drip fluids was adequate enough so that any one of the three can be used for U-67590A administration. However, the stability was reduced when aminophylline co-existed in the admixtures because of increased pH levels. In this case, the stability depended on the strength of U-67590A SS added and the drip fluid used. In terms of chemical stability, Solita-T No. 3 was most favorable when admixed with aminophylline injectable. The fastest degradation was observed in normal saline containing aminophylline. This instability was caused by the higher ionic strength. Dextrose did not seem to affect the stability of U-67590A significantly. The Solita-T No. 3 admixture had the lowest pH, thereby overcoming the negative effect of ionic strength and giving the highest stability among the three admixtures. The stability of U-67590A in direct admixture with Neophylline^R also depended on the strength of U-67590A; the stability increased with strength of U-67590A.