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Study on the Specific Impurities in Ozagrel Sodium and Sodium Chloride Injections

Yu Ming,Zhang Di,Li Mo,Sun Kuan(Liaoning Institute for Food and Drug Control,Shenyang 110023,China)  
Objective: To study the specific impurities in ozagrel sodium and sodium chloride injections.Method: Two specific impurities in 44 batches of ozagrel sodium and sodium chloride injections were determined by HPLC/MS and HPLC.Result: The structures of the two specific impurities were inferred.In the tested ozagrel sodium and sodium chloride injections,the content of impurityⅠand Ⅱwas 0.06%-0.24% and 0-0.26%,respectively.Conclusion: ImpurityⅠis related with the synthesis route of ozagrel.ImpurityⅡis the degradation product produced in the preparation process of the injections.
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