Study on the validation of microbial limit test method for Tongbianling Capsules of different manufactures
ZHENG Zhao-xian
ZHANG Xiu-hua
LI Rui-ying
QIU Quan-yi
WANG Yu-zhi
Abstract：Objective To establish a microbial limit test method of Tongbianling CaPsules through the validation of dif-ferent manufacturers of the same sPecies verification methodology. Methods The recovery Percent of five Positive bacteria was measured by inoculating rePresentative Positive strains using routine method and culture medium dilution method as the requirements of Chinese Pharmacopoeia,2010. Results The studied object had antimicrobial ProPerties and the recovery Percent of the five Positive bacteria are higher than 70% using culture medium dilution method. Conclusion Bacteria detec-tion can be tested by the culture medium dilution method,mold,yeast and control bacteria can be tested by routine method.
Keywords：Tongbianling caPsulesMicrobial limit testsRecoveryMethodology validation
Publication Date：2014-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：3( 459-460,463 )