Quality evaluation and research of cytochrome C injection / 中国药学杂志

ABSTRACT

OBJECTIVE: To evaluate the quality status and current standard of cytochrome C injection and to carry out exploratory research on its standard. METHODS: Samples were tested according to the current quality standard in the Pharmacopoeia of the People's Republic of China (2010) Volume II- Exploratory researches including peptide mapping analysis, activity determination by TMB substrate ehromogenic method, and related substances detection by HPLC were carried out. RESULTS: The passing rate of cytochrome C injection was 100%, and that of freeze-dried cytochrome C powder for injections was 50%. CONCLUSION: There existed some problems with both the quality status and current standard of cytochrome C injection. The exploratory researches indicate that it is necessary to improve the statutory standard of cytochrome C.