Determination of Degree of Crystallinity of Pantoprazole Sodium Sesquihydrate by Thermogravimetric Analysis

Abstract

Determination of degree of crystallinity by the available general comparative analytical techniques require reference materials of single phase or mixture of known amount of phases to compare with. Current study explores thermogravimetric analysis (TGA) as a tool to determine the absolute degree of crystallinity of a class of Active Pharmaceutical Ingredients, and this method uses no reference material for comparison. Pantoprazole sodium sesquihydrate, an API has been used to demonstrate the application. Hi-Res dynamic TGA experimentation is used to accurately determine the weight loss due to bound water and the same is confirmed by VT-PXRD experiments. The degree of crystallinity is calculated using the amount of bound water. The result (84.7 %) was found to be comparable with the value (82.4 %), calculated from PXRD profiles.