Preparation of impurity C in benzathine benzylpenicillin products / 中国药学杂志

ABSTRACT

OBJECTIVE: To prepare impurity C in benzathine benzylpenicillin products. METHODS: Using the mother liquor of benzathine benzylpenicillin, impurity C was prepared by means of vacuum distillation, column chromatography, and recrystallization. Its molecular structure was confirmed with UV, IR, MS, NMR and elemental analysis. Its purity and correction factor were determined by HPLC method. The contents of impurity C in the samples were determined by external standard method. RESULTS: The prepared product was proved to be impurity C by structure confirmation. CONCLUSION: The preparation of impurity C in benzathine benzylpenicillin products has important significance for the control of related substances of benzathine benzylpenicillin products.