Validation of microbial limit test for six hospital preparations

CHEN Jing; YAN Jia; ZHONG Guixiang; SONG Hongtao

doi:10.3969/j.issn.1006-0111.2019.06.011

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Objective To establish microbial limit test methods for 6 hospital preparations. Methods The tests were carried out according to the requirements of provision 1105,1106 and 1107 of rules of preparation in volume IV of Chinese pharmacopoeia 2015 edition.Test samples were treated by membrane filtration.Experiments were made on microorganism introduction method,the volume of rinsing solution and dilution ratio of the test solution. Results The method of membrane filtration could eliminate the bacteriostasis of samples.Introduction of validation strains in the sample solution worked for 6 samples in the test of total number of aerobic bacteria,molds and yeasts.The recovery ratios of five tests bacterial were within a range from 0.5 to 2.0.The membrane filtration was used for control bacteria in all preparations,and the control bacteria could be detected. Conclusion The methods met the requirements of Chinese pharmacopoeia(2015 edition),which could be used for routine work of drug quality control.

Validation of microbial limit test for six hospital preparations

Department of Pharmacy, No. 900 Hospital of the Joint Logistics Support Force, Fuzhou 350025, China

Received Date: 2019-02-24

Rev Recd Date: 2019-05-30

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Abstract: Objective To establish microbial limit test methods for 6 hospital preparations. Methods The tests were carried out according to the requirements of provision 1105,1106 and 1107 of rules of preparation in volume IV of Chinese pharmacopoeia 2015 edition.Test samples were treated by membrane filtration.Experiments were made on microorganism introduction method,the volume of rinsing solution and dilution ratio of the test solution. Results The method of membrane filtration could eliminate the bacteriostasis of samples.Introduction of validation strains in the sample solution worked for 6 samples in the test of total number of aerobic bacteria,molds and yeasts.The recovery ratios of five tests bacterial were within a range from 0.5 to 2.0.The membrane filtration was used for control bacteria in all preparations,and the control bacteria could be detected. Conclusion The methods met the requirements of Chinese pharmacopoeia(2015 edition),which could be used for routine work of drug quality control.

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Reference (10)

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Validation of microbial limit test for six hospital preparations

doi: 10.3969/j.issn.1006-0111.2019.06.011

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