The effects of grinding and drying on the solid state stability of sodium prasterone sulfate.

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The effects of grinding and drying (removal of water of crystallization) processes on the solid state stability of sodium prasterone sulfate (DHA·SO3Na·2H2O) were studied. As the grinding time was increased, the sample became more unstable. From the study of the thermal behavior of the water of crystallization, it was suggested that the bonding force between the water of crystallization and DHA·SO3Na molecule within the hydrate crystal was weakened by grinding, and water molecules participated in the hydrolysis of DHA·SO3Na more easily. Although DHA·SO3Na was found to be hydrolyzed, the ground DHA·SO3Na·2H2O was more stable under conditions of high humidity than low humidity. This result is very interesting, and it was considered that the bonding force between the water of crystallization and DHA·SO3Na molecule was strengthened in conditions of high humidity. The dehydration of DHA·SO3Na·2H2O resulted in a higher disorder of the crystal structure and water molecules were sufficiently free to participate in a solid state hydrolytic reaction. Therefore, partially dehydrated DHA·SO3Na·2H2O decomposed easily. After almost complete removal of the water of crystallization, the sample was relatively stable, since it contained few water molecules which could participate in hydrolysis. The dihydrate form was the most stable.

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