Influence of impurities on the specific optical rotation of cefozopran.

Shu-Yu Liu, Ya-Ping Li, Chang-Qin Hu

Die Pharmazie 2012 Jul

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The impurities of cefozopran hydrochloride are analyzed using high-performance liquid chromatography (HPLC) with UV absorbance and optical rotation (OR) detection. The results show that the impurities can affect the specific optical rotation of the cefozopran product. Due to the different composition of impurities, the Chinese cefozopran hydrochloride product has a specific optical rotation different from the Japanese product. The relationship between impurity limits and specific optical rotation of cefozopran hydrochloride is revealed. The results provide a scientific rationale for setting the limit of specific optical rotation of cefozopran hydrochloride.