H. Okamoto et al., COMPATIBILITY OF U-67590A STERILE SOLUTION WITH NORMAL SALINE, DEXTROSE SOLUTION, AND SOLITA-T NO-3 WITH OR WITHOUT AMINOPHYLLINE INJECTABLE, Drug development and industrial pharmacy, 20(16), 1994, pp. 2479-2492
The compatibility of U-67590A sterile solution (SS) with three drip fl
uids (normal saline, 5% dextrose solution, and Solita-T No. 3) and Neo
phylline(R) (an aminophylline injectable) was studied. The entire volu
me or U-67590A SS in an ampoule was transferred into each of the drip
fluid containers (500 mL fill). The container was laid under fluoresce
nt 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 sta
bility of U-67590A in these drip fluids was adequate enough so that an
y one of the three can be used for U-67590A administration. However, t
he stability was reduced when aminophylline co-existed in the admixtur
es because of increased pH levels. In this case, the stability depende
d on the strength of U-67590A SS added and the drip fluid used. In ter
ms of chemical stability, Solita-T No. 3 was most favorable when admir
ed with aminophylline injectable. The fastest degradation was observed
in normal saline containing aminophylline. This instability was cause
d by the higher ionic strength. Dextrose did not seem to affect the st
ability of U-67590A significantly. The Solita-T No. 3 admixture had th
e lowest pH, thereby overcoming the negative effect of ionic strength
and giving the highest stability among the three admixtures. The stabi
lity 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.