Validation on Method of Microbial Limit Test of Povidone Iodine Solution
- VernacularTitle:聚维酮碘溶液微生物限度检查方法验证
- Author:
Xingfa YE
;
Yanyan DU
;
Lijuan DONG
- Publication Type:Journal Article
- Keywords:
Povidone iodine solution;
Microbial limit test;
Methodological validation;
Membrane-filter procedure
- From:
China Pharmacy
2005;0(16):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To establish a microbial limit test method for povidone iodine solution.METHODS:Validation on methodology of the microbial limit test of povidone iodine solution was performed using plating method(Ⅰ),culture agent dilution method(Ⅱ),membrane-filter procedure method(Ⅲ)and sodium thiosulfate neutralization in combination with membrane-filter procedure method(Ⅳ).RESULTS:The recovery rates of all of the test organisms in method Ⅰ and method Ⅱ approached zero,less than 70% in method Ⅲ but above 85% in method Ⅳ.The growth of the control bacteria was abnormal in method Ⅱand method Ⅲ,but normal in method Ⅳ.CONCLUSION:It is advisable to adopt the method Ⅳ for microbial limit test of povidone iodine solution.