Validation of Methodology on the Microbial Limit Test for Akafen Powder / 中国药房

ABSTRACT

OBJECTIVE:To establish a microbial limit test method for Akafen powder and validate the methodology.METHODS:The three methods for microbial limit test in appendices volume Ⅱ of Chinese Pharmacopoeia(2005 Edition)were adopted to study Akafen powder.The optimal test method was obtained by comparing the recovery rates of test organisms.RESULTS:According to the results,the recoveries of five test bacteria of Akafen powder by plating method were less than 70% versus above 85% by membrane-filter procedure.The the test organisms were successfully detected in the control bacteria test by media dilution method.CONCLUSION:Membrane-filter procedure is advisable for the test of bacteria,mould and yeast fungus,while media dilution method is advisable for the control bacteria test.