Preparation and stability of intravenous solutions of sodium dichloroacetate (DCA).

Abstract

An IV injection formulation of sodium dichloroacetate (DCA) was prepared without heat sterilization, and examined for stability. DCA is heat labile in aqueous solutions. Its decomposition involves dehalogenation and production of hydrogen ions. Decomposition occurs relatively rapidly at relatively low pH values, and is promoted by heating. Injection solutions should be prepared aseptically and sterilized by filtration. Solutions prepared aseptically and sterilized by filtration are stable stored at 4 degrees C for at least four yrs.