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How to Evaluate Solid Pharmaceutical Drugs (2): Confirming the Presence/Absence of Amorphous Substance

AppNote XRD1002: Confirming the Presence/Absence of Amorphous Substance

Background

Solid pharmaceutical drugs are known to have different physical properties, such as solubility, bioavailability and stability, depending on their crystal form. This is why these drugs are productized in specific crystalline forms. However, solid pharmaceutical drugs are subject to processing such as grinding, drying, and tableting during manufacturing (formulation), which may lead to polymorphic transition and amorphization. Because amorphous components have physical properties different from crystalline components, confirming the presence/absence of amorphous substances and crystallinity is important in the production of solid pharmaceutical drugs.

We introduce a method for determining the presence/absence of an amorphous substance by differential scanning calorimetry (DSC) and powder X-ray diffraction measurement (XRD). In addition, we also introduce the crystallinity calculation method by the multiple peaks decomposition method for powder X-ray diffraction measurement.

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