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- Title
Quantification of solid-state impurity with powder X-ray diffraction using laboratory source.
- Authors
Sundaram, Meenakshi; Natarajan, Saravanan; Dikundwar, Amol G.; Bhutani, Hemant
- Abstract
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.
- Publication
Powder Diffraction, 2020, Vol 35, Issue 4, p226
- ISSN
0885-7156
- Publication type
Article
- DOI
10.1017/S0885715620000500