Validation of Methodology on the Microbial Limit Test for Akafen Powder
- VernacularTitle:阿咖酚散微生物限度检查方法的验证
- Author:
Haihua WANG
- Publication Type:Journal Article
- Keywords:
Akafen powder;
Microbial limit test;
Validation of the methodology
- From:
China Pharmacy
2007;0(28):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To establish a microbial limit test method for Akafen powder and validate the methodology.METHODS:The three methods for microbial limit test in appendices volume Ⅱ of Chinese Pharmacopoeia(2005 Edition)were adopted to study Akafen powder.The optimal test method was obtained by comparing the recovery rates of test organisms.RESULTS:According to the results,the recoveries of five test bacteria of Akafen powder by plating method were less than 70% versus above 85% by membrane-filter procedure.The the test organisms were successfully detected in the control bacteria test by media dilution method.CONCLUSION:Membrane-filter procedure is advisable for the test of bacteria,mould and yeast fungus,while media dilution method is advisable for the control bacteria test.
