Method suitability study of sterility test for moxifloxacin hydrochloride eye drops
10.19778/j.chp.2025.05.016
- VernacularTitle:盐酸莫西沙星滴眼液无菌检查的方法适用性研究
- Author:
Xiaobai XUE
1
;
Hong JIANG
1
;
Tingting GAO
1
;
Dan ZHENG
1
Author Information
1. 沈阳兴齐眼药股份有限公司,沈阳 110163
- Publication Type:Journal Article
- Keywords:
moxifloxacin hydrochloride eye drops;
sterility test;
membrane filtration;
method suitability test of sterility
- From:
Drug Standards of China
2025;26(5):549-555
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish the method sterility test for moxifloxacin hydrochloride eye drops.Methods:According to the requirements of Chinese Pharmacopoeia(2020 edition,volume Ⅳ),method suitability test of sterility test for moxifloxacin hydrochloride eye drops that treated with using different flushing fluid and adding neutralizer was performed for membrane-filter procedure.Results:The method was accepted with adding 5 mL 2 mol·L-1 magnesium sulfate solution into the culture media as neutralizer and flushing with 300 mL buff-ered sodium Chloride-Peptone Solution pH 7.0.The test groups grew synchronously with the positive strains while the negative control had no strain growth.Conclusion:The established method is effective and feasible and can be used for the sterility test of moxifloxacin hydrochloride eye drops.
