The application of powder X-ray diffraction (PXRD) for the detection and quantification of low levels of a solid-state chemical impurity, BrettPhos oxide, in an active pharmaceutical ingredient is discussed. It is demonstrated that with appropriate methodology and experimentation, the impurity levels of as low as 0.07% w/w could be detected reliably and limit of quantification of 0.10% w/w could be achieved by PXRD, using a laboratory X-ray source. Method development, validation, and benchmarking using conventional high-performance liquid chromatography are presented in the manuscript highlighting the robustness and reproducibility of such measurements.

中文翻译：

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使用实验室源通过粉末 X 射线衍射对固态杂质进行定量

讨论了粉末 X 射线衍射 (PXRD) 在检测和量化活性药物成分中低水平的固态化学杂质 BrettPhos 氧化物中的应用。结果表明，通过适当的方法和实验，可以可靠地检测低至 0.07% w/w 的杂质水平，并且可以使用实验室 X 射线源通过 PXRD 实现 0.10% w/w 的定量限。手稿中介绍了使用传统高效液相色谱的方法开发、验证和基准测试，强调了此类测量的稳健性和可重复性。