Erythromycin dry suspension ring ester Method for Microbial Limit Tests.docVIP

 PAGE \* MERGEFORMAT 9 Erythromycin dry suspension ring ester Method for Microbial Limit Tests [Abstract] Objective of the ring ester of erythromycin dry suspension verification test to determine the appropriate method of Microbial Limit Tests. Methods and results of bacteria using membrane filtration method, when the amount of 1 000 mL washing may eliminate inhibitory effect; fungi tested using conventional method, the recovery rate of artificial fungal contamination were higher than 70%. Conclusion ring ester of erythromycin dry microbial limit bacterial suspension should be used membrane filtration method, washing capacity of 1 000 mL; fungi tested using conventional method, Escherichia coli using membrane filtration method, washing volume of 800 mL. [Keywords:] Microbial Limit Tests Methods membrane filtration method conventional method antibacterial Ring ester of erythromycin macrolide antibiotics for new dry suspension is a semi-synthetic derivatives of erythromycin, ring after erythromycin reduced the esterification of serum protein binding rate, increased antimicrobial activity and reduced toxicity; product is broad-spectrum antibiotics, quality standards not listed in their registration limits of microbial testing methods. To this end, the paper dry suspension ring ester of erythromycin microbiological examination of the limits of method has been validated test. A test material 1.1 Sample dry suspension ring ester of erythromycin, batch number: 061,101, Specification: 0.125 g / bag, producers: Hainan Macao, the United States and China Pharmaceutical Co., Ltd.. 1.2 bacteria [1] E. coli CMCC (B) 44102, Bacillus subtilis CMCC (B) 63501, Staphylococcus aureus CMCC (B) 26003, Candida albicans CMCC (F) 98001, Aspergillus niger CMCC (F) 98003 by the Chinese pharmaceutical and biological products available. 1.3 Rose Red sodium agar medium, batch number: 040,929; nutrient agar, Batch No: 060,214; nutrient broth, batch number: 060,117; fungal culture medi