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Quantitative analysis of polymorphic impurities in a drug substance by the calibration method using a benchtop X-ray diffractometer

AppNote XRD1081: Quantitative analysis of polymorphic impurities in a drug substance by the calibration method using a benchtop X-ray diffractometer

 

Phase transitions of drug substances to polymorphs or pseudopolymorphs sometimes occur because of temperature and humidity effects. Polymorphs and pseudopolymorphs can differ in solubility and absorption time, so it is important to control and evaluate them during drug development and manufacturing. Here is an example where we calculated the amount of polymorph impurities in a drug substance using a high-speed 1D detector, which can obtain intensity data sufficient for qualitative and quantitative analysis in a short period of time, with a benchtop X-ray diffractometer to determine the diffraction data and perform quantitative analysis by the calibration method.

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