RESUMEN
OBJECTIVE: To investigate the impurity profile of cloxacillin sodium for injection and study the source of major impurities. METHODS: The impurities in samples from seven manufacturers were profiled by an optimized reversed-phase HPLC method and a newly established normal-phase HPLC method. The major impurities were prepared by semi preparation technology and identified by LC-QTOF-MS, 1H-NMR and 13C-NMR. RESULTS: Two new impurities relating with the salt-forming reaction and the purification process respectively, and four other new impurities were all successfully identified in this study. CONCLUSION: The study is suitable for profiling the impurities in cloxacillin sodium for injection and is quite useful for enhancing the quality control.
RESUMEN
0.05). The total costs were(1 184.93?321.72),(1 532.59?426.35) and (1 830.35?311.83)yuan, respectively(P