Quality Test of Ketotifen Eye Drops Prepared in Hospital : (2) The Irritability Test

Stability on preservation of Ketotifen Eye Drops prepared in our hospital for treatment of conjunctivitis due to Japanese cedar pollinosis was examined. The suitability of its heat sterilization was also studied. After storing for 3 months at room temperature or 6 months in a cold place, no changes were observed in appearance and physical properties of the solution. The rate of residual Ketotifen was more than 90%. After sterilization at 105°C for 15 minutes, coloration, .decrease in content, decomposed products were observed, and sterilization by heating seemed impossible. However, it is considered that Ketotifen Eye Drops be useful if it is prepared in the germ-free conditions and preserved in a cold place.