Given that impurities may affect the quality and safety of drug products,impurity identification and profiling is an integral part of drug quality control and is particularly important for newly developed medications ...Given that impurities may affect the quality and safety of drug products,impurity identification and profiling is an integral part of drug quality control and is particularly important for newly developed medications such as solriamfetol,which is used to treat excessive daytime sleepiness.Although the highperformance liquid chromatography analysis of commercial solriamfetol has revealed the presence of several impurities,their synthesis,structure elucidation,and chromatographic determination have not been reported yet.To bridge this gap,we herein identified,synthesized,and isolated eight processrelated solriamfetol impurities,characterized them using spectroscopic and chromatographic techniques,and proposed plausible mechanisms of their formation.Moreover,we developed and validated a prompt impurity analysis method based on ultrahigh-performance liquid chromatography with UV detection,revealing that its selectivity,linearity,accuracy,precision,and quantitation limit meet the acceptance criteria of method validation stipulated by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.Thus,the developed method was concluded to be suitable for the routine analysis of solriamfetol substances.展开更多
Zinc oxide（ZnO） has a wide band gap, high stability and a high thermal operating range that makes it a suitable material as a semiconductor for fabricating light emitting diodes（LEDs） and laser diodes, photodiodes...Zinc oxide（ZnO） has a wide band gap, high stability and a high thermal operating range that makes it a suitable material as a semiconductor for fabricating light emitting diodes（LEDs） and laser diodes, photodiodes, power diodes and other semiconductor devices. Recently, a new crystal growth for producing ZnO crystal boules was developed, which was physical vapor transport（PVT）, at temperatures exceeding 1500 ？C under a certain system pressure. ZnO crystal wafers in sizes up to 50 mm in diameter were produced. The conditions of ZnO crystal growth, growth rate and the quality of ZnO crystal were analyzed. Results from crystal growth and material characterization are presented and discussed. Our research results suggest that the novel crystal growth technique is a viable production technique for producing ZnO crystals and substrates for semiconductor device applications.展开更多
基金This research was funded by the Deanship of Scientific Research at the German-Jordanian University and the Deanship of Scientific Research at Zarqa University.The graphical abstract was created with BioRender software.
文摘Given that impurities may affect the quality and safety of drug products,impurity identification and profiling is an integral part of drug quality control and is particularly important for newly developed medications such as solriamfetol,which is used to treat excessive daytime sleepiness.Although the highperformance liquid chromatography analysis of commercial solriamfetol has revealed the presence of several impurities,their synthesis,structure elucidation,and chromatographic determination have not been reported yet.To bridge this gap,we herein identified,synthesized,and isolated eight processrelated solriamfetol impurities,characterized them using spectroscopic and chromatographic techniques,and proposed plausible mechanisms of their formation.Moreover,we developed and validated a prompt impurity analysis method based on ultrahigh-performance liquid chromatography with UV detection,revealing that its selectivity,linearity,accuracy,precision,and quantitation limit meet the acceptance criteria of method validation stipulated by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.Thus,the developed method was concluded to be suitable for the routine analysis of solriamfetol substances.
基金Project supported by the Special Scientific Research Plan Project of Shaanxi Provincial Education Department,China(No.08JK376)
文摘Zinc oxide（ZnO） has a wide band gap, high stability and a high thermal operating range that makes it a suitable material as a semiconductor for fabricating light emitting diodes（LEDs） and laser diodes, photodiodes, power diodes and other semiconductor devices. Recently, a new crystal growth for producing ZnO crystal boules was developed, which was physical vapor transport（PVT）, at temperatures exceeding 1500 ？C under a certain system pressure. ZnO crystal wafers in sizes up to 50 mm in diameter were produced. The conditions of ZnO crystal growth, growth rate and the quality of ZnO crystal were analyzed. Results from crystal growth and material characterization are presented and discussed. Our research results suggest that the novel crystal growth technique is a viable production technique for producing ZnO crystals and substrates for semiconductor device applications.
