Study on Microbiological Examination Methods of Zoledronic Acid and Zoledronic Acid Injection

OBJECTIVE To establish the method of microbial limit test of zoledronic acid and the method of sterility test of zoledronic acid injection.METHODS The method validation was conducted by microbial limit test from appendixes in Chinese Pharmacopeia (Edition 2015).RESULTS Microbial limit test of zoledronic acid was using membrane filtration method,the recoveries of the total number of aerobic bacteria,molds and yeasts were between 0.5 and 2,Escherichia coli could be detected in the Escherichia coli test group.The sterility test of zoledronic acid injection was using membrane filtration,and the six test bacteria could be detected.CONCLUSION The microbiological examination methods of zoledronic acid and zoledronic acid injection is used membrane filtration method.