Quality analysis of domestic pefloxacin mesilate for injection
Pages: 491-495
Year: 2017 Issue: 6
Journal: Chinese Journal of Antibiotics
Abstract: Objective Based on the test and the research of pefloxacin mesilate for injection,analyzed and evaluated the quality including the safety,the effectiveness and the controllability.Methods The nationwide pefloxacin mesilate for injection was tested according to the official quality standards.The quality was analyzed by using multiple statistical methods.The products from different manufacturing enterprises were compared.We performed an exploratory research on related substances,alkyl sulfonic acid ester impurities and safety factors.Results Thirty batches of samples from eight manufacturing enterprises were tested;the pass rate is 100％.Methods in Chinese Pharmacopoeia 2010 and European Pharmacopoeia 2013 were used for detecting related substances of pefloxacin mesylate for injection,respectively.The content of the main impurity and the total impurity determined by the two methods above were equivalent.The number of the impurities detected using the ChP2010 method was more than that using the EP2013 method.The resolution was better than EP2013's.The determination method for methylmethanesulfonate (MMS),ethyl methanesulfonate (EMS) and isopropyl methanesulfonate (IMS) in pefloxacin mesilate by GC-MS was established.None of the methanesulfonic acid ester impurities were detected in six batches of the materials and thirty batches of the injections.The active allergic reactions,antihypertensive substances,hemolysis and coagulation of pefloxacin mesylate for injection were investigated.The results were negative or conform to regulations.Conclusion The official quality standards of pefloxacin mesilate injections are effective to control the quality.Therefore,the quality was all right in general.
Year: 2017 Issue: 6
Journal: Chinese Journal of Antibiotics
Abstract: Objective Based on the test and the research of pefloxacin mesilate for injection,analyzed and evaluated the quality including the safety,the effectiveness and the controllability.Methods The nationwide pefloxacin mesilate for injection was tested according to the official quality standards.The quality was analyzed by using multiple statistical methods.The products from different manufacturing enterprises were compared.We performed an exploratory research on related substances,alkyl sulfonic acid ester impurities and safety factors.Results Thirty batches of samples from eight manufacturing enterprises were tested;the pass rate is 100％.Methods in Chinese Pharmacopoeia 2010 and European Pharmacopoeia 2013 were used for detecting related substances of pefloxacin mesylate for injection,respectively.The content of the main impurity and the total impurity determined by the two methods above were equivalent.The number of the impurities detected using the ChP2010 method was more than that using the EP2013 method.The resolution was better than EP2013's.The determination method for methylmethanesulfonate (MMS),ethyl methanesulfonate (EMS) and isopropyl methanesulfonate (IMS) in pefloxacin mesilate by GC-MS was established.None of the methanesulfonic acid ester impurities were detected in six batches of the materials and thirty batches of the injections.The active allergic reactions,antihypertensive substances,hemolysis and coagulation of pefloxacin mesylate for injection were investigated.The results were negative or conform to regulations.Conclusion The official quality standards of pefloxacin mesilate injections are effective to control the quality.Therefore,the quality was all right in general.
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