Comparison of two melting range analysis methods with lactitol monohydrate

Abstract In pharmacopoeia, the melting point is determined by a standard method with a melting point instrument. The melting point can also be determined with differential scanning calorimetry (DSC). In this study, the standard method and DSC method are compared for determining the melting range of lactitol monohydrate. The effect of initial temperature, grinding, and drying on the melting range of different lactitol monohydrate samples was studied by a melting point instrument. The melting point and melting enthalpy of the stable form of lactitol monohydrate was identified by DSC. The statistical analysis of the results is based on a t-test. All studied variables had a small effect on the …