Analysis of related substances of mupirocin raw material and ointment
Objective:To determine the key process parameters during production and storage by analyzing the impurity profiles of mupirocin raw materials and ointments from different manufacturers,to provide data support for the quality evaluation of mupirocin ointment.Methods:Column switch HPLC-MS was applied to establish the impurity profiles of mupirocin raw material and ointment,and the impurities produced in the stressing test were analyzed.X-ray was applied to analyze the crystal form of the raw material.Results:The characteristic impurity profiles of mupirocin raw material and ointment were established,nine impurities were detected,and the sources of impurities were summarized.The raw materials of different manufacturers were all crystal form.Conclusion:The main impurities in mupirocin ointment come from raw materials,and the degradation impurities are mainly affected by pH,temperature and light.The relative content of process impurities in raw materials and preparations could be used as an index to investigate the differences in production processes,and the main degraded impurities could be used as an index to analyze whether the temperature and light control in the process of production,packaging and storage is reasonable.
NETL
NSTL
万方数据
