Cefoxitin sodium: solution and solid-state chemical stability studies.

Abstract

Studies were undertaken to provide the basic physicochemical information necessary for preparing a suitable parenteral formulation of cefoxitin sodium. Emphasis was placed on the physico-chemical properties of the compound in solution and in the solid state. Cefoxitin sodium is very soluble in water and exhibits apparent first-order decomposition in this medium at pH 3-9. Maximum stability in water is at pH 5-7. Under these pH conditions, cefoxitin sodium loses about 10% of its activity in 2 days at 25 degrees. Thermal decomposition rates for amorphous and crystalline cefoxitin sodium samples were determined. Amorphous cefoxitin sodium was considerably less stable than its corresponding crystalline form. Solid-state decomposition plots are biphasic, displaying initial rapid losses followed by a slower decay period. The extent of loss in the crystalline solid at the end of the more rapid initial phase can be correlated with the water content of the solid.