Effect of Environment on Crystallinity and Chemical Stability in Solid-State of Ground Cephalotin Sodium During Storage

Abstract

Effects of environmental conditions on the crystallinity and the decomposition point (Dp) of ground cephalotin sodium during storage were investigated by X-ray diffraction and differential thermal analysis (DTA). The X-ray diffraction peaks of ground products increased after storage at 0% and 75% relative humidity (R.H.), at 35° C. The crystallinity of ground product increased at 75% R.H. and 0% R.H., 35°C, but that of ground product at 0% R.H., -30°C was not changed. The Dp measured by DTA of the ground product increased from 189.5°C to 197°C after 4 days at 75% R.H., but the Dp of the ground product at 0% R.H., -30°C for 4 days was 190.1°C. Relation between the Dp and the crystal Unity of ground cefalotin sodium was a straight suggesting that the thermal stability of cefaiotin sodium in the solid-state depends on the degree of crystallinity.