Roxithromycin microbial limit test for validation.docVIP

 PAGE \* MERGEFORMAT 6 Roxithromycin microbial limit test for validation [Abstract] Objective: To validate a Roxithromycin microbial limit method. Methods: The membrane filtration tests, using ‘The 2005 edition of Chinese Pharmacopoeia method of income verification set. Results: The five kinds of strain recovery rate higher than 70%, and check with the exclusive control of bacteria. Conclusion: The use of membrane filtration method checks Roxithromycin viable microbial limit. [Keywords:] Roxithromycin tablets; Microbial Limit Tests; membrane filtration method [Abstract] Objective: To establish a microbial limit test method for Roxithromycin Tablets. Methods: Filtration and verification method of Chinese Pharmacopoeia 2005 were used.Results: The recoveries were more than 70% and the quality of control germ check was credible. Conclusion: Membrane-filter can be used in microbial limit test for Roxithromycin Tablets. [Keywords:] Roxithromycin Tablets; Microbial limit test; Membrane-filter Roxithromycin has bactericidal effect on microbial growth of interference, according to conventional methods of determination of the limits of its micro-organisms can not guarantee the accuracy of results, methodological verification is the only way to ensure results are accurate. An apparatus and materials 1.1 Instrument Open thin-film filter (pore size 0.45 μ rn, membrane diameter 50 mm), constant temperature incubator, petri dishes, leaching pump. 1.2 Sample Roxithromycin tablets (Franc pharmaceutical, batch number: 070301,070501; city of Shenyang Pharmaceutical Pipe Co., Ltd., batch number: 20,061,101). 1.3 medium Nutrient agar, Rose Red sodium agar, bile lactose by bacilli, 4 - methylumbelliferyl glucuronide (MUG) medium, were purchased from Chinese medicine and biological products. 1.4 dilution liquid and flushing fluid sterile sodium chloride pH of 7.0 - peptone buffer. 1.5 bacteria Escherichia coli, Bacillus subtilis, Staphylococcus aureus, Candida alb