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Quantitative Determination of Crystallinity of α-Lactose Monohydrate by DSC


In pharmaceutical practice it is important and useful to know the crystallinity of materials and to monitor it during formulation development, production processes and storage. The purpose of this study was to assess the quantitative capability of DSC for determining crystallinity in crystalline/amorphous powder mixtures and to compare the accuracy of the DSC method with that of conventional powder X-ray diffraction. Alpha-lactose monohydrate was chosen as the model material. On the basis of this study it can be concluded, that DSC method can be applied safely for semiquantitative evaluation of the crystallinity of lactose samples consisting of an amorphous content higher than 20%.

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GombÁs, Á., Szabó-Révész, P., Kata, M. et al. Quantitative Determination of Crystallinity of α-Lactose Monohydrate by DSC. Journal of Thermal Analysis and Calorimetry 68, 503–510 (2002).

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  • crystallinity
  • DSC
  • lactose
  • X-ray powder diffraction