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| The suitability test of sterility test for Metronidazole and Sodium Chloride Injection |
| XIA Tian CUI Ying LI Hongduo SHA Miao REN Wenxin |
| Microbiology Laboratory, Xi′an Institute for Food and Drug Control, Shaanxi Province, Xi′an 710000, China |
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Abstract Objective To establish optimized sterility test method of Metronidazole and Sodium Chloride Injection according to the suitability test of sterility test for Metronidazole and Sodium Chloride Injection by the sterility test method (general rule 1101) in Chinese Pharmacopoeia (2015). Methods The test applied membrane filtration method and used 0.1% sterile peptone solution as rinse solution. The rinsing amount of per membrane was increased from 100 mL to the maximum amount of 1000 mL per membrane. Three separate tests were performed. The sample was directly rinsed with the rinse solution for the first time, the rinse solution containing 0.13% and 0.2% polysorbate 80 were used for the second and third time respectively. Results In test one, the Clostridium sporogenes test group did not grow; in test two, the test group grew well when the rinsing amount reached the maximum (1000 mL per membrane); in test three, the antibacterial effect of Metronidazole could be eliminated and the test group grew well when the rinsing amount reached 500 mL per membrane. Conclusion Metronidazole Sodium Chloride Injection (100 mL: Metronidazole 0.5 g and Sodium Chloride 0.8 g) should be sterilized by membrane filtration (10 bottles for each filter cartridge, 0.1% sterile peptone solution containing 0.2% polysorbate 80 as the rinse solution, rinsed for 5 times, 100 mL/time per film), using Clostridium sporogenes as a positive control.
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