Osamu Fujishita

Stability and Potency of Sterilized Chlorhexidine Gluconate Solutions after Unsealing the Container

Sterilized chlorhexidine gluconate solutions (GCH) in 500 ml polypropylene containes are prepared in our hospital pharmacy. To determine the expiration period after unsealing the container, the stability and potency of 0.02% GCH were examined by high-performance liquid chromatography and cultivation tests, respectively. The main ingredient of 0.02% GCH which had been used partially for more than 6 months, was maintained at over 95% of its initial concentration at room temperature. No bacterium nor fungus was evident in the 0.02% GCH partially used at several sections for 2-15 months, when examined by three different cultivation tests. Under the conditions of excess microbe contamination such as falling microbial test and sticking fingers test, 0.02% GCH prevented the growth of microbes. These results suggest that there is only a minor possibility of microbial contamination in the sterilized 0.02% GCH after the container has been unsealed.In general, this preparation may be usable for at least one month after unsealing although the existence of microbes resistant to GCH has been reported.

Evaluation of Some Small Volume Injections by Particle Counter Method.

Small volume injections (SVIs) of NaHCO3 and heparin used in the United States have been reported to contain 60-70% of the maximum allowable number of particles described in United States Pharmacopeia (USP). We evaluated SVIs of KC1, CaCl2, NaHCO3 and heparin used in Japan using the electronic liquid-borne particle system. All SVIs examined showed remarkably lower numbers of particles than the limits described in USP. Even if several injections of each preparations are used together, the particle number may not exceed the USP limits.