Quantification of drug Amorphous fraction by DSC

The technological operations for the production of a solid dosage form might produce a partial amorphization of the drug that can significantly change its efficacy and stability. For this reason, the ability to detect also low amounts of amorphous phase in a crystalline matrix is a key point. In this work, partial amorphization has been produced in crystalline samples of perphenazine through high-energy milling and the amount of the amorphous phase has been determined by differential scanning calorimetry. It is shown that the technique is able to measure quite low amounts of amorphous phase with good accuracy/precision.