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Application note

Quantitative XRD - Detection of low amounts of crystalline impurities for pharmaceutical process control

X’Pert PRO MPD and CubiX FAST diffraction systems equipped with the X’Celerator detector, offer excellent low limits of detection for pharmaceutical polymorphic phases – down to a tenth of a percent. They also offer a significantly shorter measurement time, or can generate greatly improved counting statistics in the same time as a traditional point detector.

X-ray powder diffraction (XRPD) can greatly enhance the manufacturing process control of active pharmaceutical ingredients (APIs) by monitoring phase(s) present, quantifying polymorphic phases, and determining sample crystallinity. In this example application, standard samples of Form I of an API were spiked with low levels of the polymorph Form II. XRPD was used to calibrate an analysis, programmed in PANalytical’s X’Pert Industry software, which could then be used for manufacturing process control to ensure that the right polymorph crystallized in the process steps.

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