Development on sterility testing methods for antibiotic drugs
Sterility testing is a statutory inspection method for sterile drugs,among which the membrane filtration method is more widely used compared to the direct inoculation of culture medium due to its advantages of easy operation,low risk,and high accuracy.There are various types of sterile drug formulations,among which antibiotic drugs have been a challenge in establishing sterility testing methods due to their diverse variety,structure,strong antibacterial properties,and wide antibacterial spectrum.This article discussed the four key steps of dissolution,filtration,rinsing,and cultivation in the membrane filtration method.Through a review of 61 established sterility testing methods for 13 categories and 47 varieties of antibiotics,the basic strategies for establishing sterility testing methods were discussed,and the limitations of sterility testing methods and results were also discussed in order to provide ideas and references for the establishment of sterility testing methods for antibiotics and the correct understanding of sterility testing results.
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