Methodological Study on Microbial Limits of Voriconazole API
OBJECTIVE Through the study of the applicability of the microbiological testing methodology for Voriconazole API,it is suggested that the establishment of microbiological testing methodology for insoluble drugs should focus on key issues.METHODS According to General Rule 1105 of the 2020 edition of the Chinese Phar-macopoeia,the applicability of the testing method was studied,and a microbial limit test method for Voriconazole API was established.RESULTS Using a membrane filtration method with a neutralizing agent,200 mL of the 1∶2000 test solution was fully filtered.The diluent and rinse were both 0.1％Tween 80(pH 7.0)sterile sodium chloride peptone buffer,with a rinse volume of 500 mL,and 100 mL each time.This could avoid the impact of the antifungal inhibitory effect of Voriconazole on the test.CONCLUSION This method can serve as a preliminary methodological applicability study for insoluble antifungal drugs.
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