Establishment and validation of sterility test of levofloxacin lactate and sodium chloride injection

LIU Dong; TANG Changming; HAO Zhe

doi:10.3969/j.issn.1006-0111.2015.06.019

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Objective To establish a sterility test of levofloxacin lactate and sodium chloride injection. Methods The test was carried out by thin-membrane filtration method with different volume of flushing liquid or adding neutralization into culture medium according to the Appendix of Chinese Pharmacopoeia (2010 edition). Results When 0.1% peptone water was used as flushing liquid, Staphylococcus aureus gave no evidence of growth until the amount of flushing liquid reached 700 ml per tube (100 ml each time). At the same time, all of the six positive control bacteria grew normally when there was 300 ml flushing liquid in each tube with neutralization as culture medium. Conclusion This method was simple and convenient, suggesting that it was suitable for the sterility test of levofloxacin lactate and sodium chloride injection.

Establishment and validation of sterility test of levofloxacin lactate and sodium chloride injection

Department of Pharmacy, No.153 Central Hospital of PLA, Zhengzhou 450042, China

Received Date: 2014-03-29

Rev Recd Date: 2014-09-01

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Abstract: Objective To establish a sterility test of levofloxacin lactate and sodium chloride injection. Methods The test was carried out by thin-membrane filtration method with different volume of flushing liquid or adding neutralization into culture medium according to the Appendix of Chinese Pharmacopoeia (2010 edition). Results When 0.1% peptone water was used as flushing liquid, Staphylococcus aureus gave no evidence of growth until the amount of flushing liquid reached 700 ml per tube (100 ml each time). At the same time, all of the six positive control bacteria grew normally when there was 300 ml flushing liquid in each tube with neutralization as culture medium. Conclusion This method was simple and convenient, suggesting that it was suitable for the sterility test of levofloxacin lactate and sodium chloride injection.

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Reference (14)

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Establishment and validation of sterility test of levofloxacin lactate and sodium chloride injection

doi: 10.3969/j.issn.1006-0111.2015.06.019

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通讯作者: 陈斌, [email protected]

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