AIMTo study the effect of both light and heat on the stability of furacilin aqueous solution and the probability of substituting for isothermal accelerated tests by nonisothermal accelerated tests upon exposure to light at high temperatures.

METHODSThe isothermal and nonisothermal accelerated tests were employed. The accelerated tests were proceeded in the dark and exposed to light at high temperature. Tungsten, ultraviolet and fluorescent lamps were employed in exposure tests.

RESULTSThe degradation of furacilin aqueous solution in isothermal heating experiments or the exposure experiments to light at high temperatures obeys zero-order kinetics. The total degradation rate constant k caused by both light and heat can be divided into two parts: k = kdark + klight, where kdark and klight are the degradation rate constant caused by heat and light, respectively. The klight can be expressed as klight = Alight.exp(-Ea,light/RT).E, where E is the illuminance of light; Alight and Ea,light are both experimental constants. The parameters obtained in nonisothermal accelerated tests were comparable to those obtained in classic isothermal accelerated tests.

CONCLUSIONNonisothermal accelerated tests may substitute for isothermal accelerated tests during the study of the effects of both light and heat on the stability of drugs, in order to save time, labor and drugs.