[Validation method for bacteria and fungi count in microbial limit test of drugs].
OBJECTIVE
To establish the validation method and criteria for counting bacteria and fungi in microbial limit test which is described in the Pharmacopeia of China (ChP) 2005.


METHODS
According to the method set up for validation, the tested microorganisms with known counts were added to samples followed by the determination of the recovery.


RESULTS
With different preparing method for testing samples, the recoveries for the tested microorganisms in testing samples were found to be over 70%.


CONCLUSIONS
Validation method for counting contaminated bacteria and fungi in drugs is recommended to follow the method established in this paper. The recovery for tested microorganisms should be not less than 70%.
Xu
Hua-Yu
HY
State Pharmacoeia Commission of China, Beijing 100050, China. xuhuayu@chp.org.cn
Du
Yun
Y
Qian
Wen-Jing
WJ
Bao
Ying
Y
Lang
Fei
F
Yuan
Lin-Na
LN
Li
Wen
W
Liang
Yue-Qiu
YQ
Shi
Rui-Mian
RM
D001234:Aspergillus niger / Q000302:isolation & purification; D001412:Bacillus subtilis / Q000302:isolation & purification; D001419:Bacteria / Q000302:isolation & purification*; D002176:Candida albicans / Q000302:isolation & purification; D015169:Colony Count, Microbial / Q000379:methods; D004340:Drug Contamination; D004365:Drugs, Chinese Herbal / Q000592:standards; D004926:Escherichia coli / Q000302:isolation & purification; D005658:Fungi / Q000302:isolation & purification*; D013211:Staphylococcus aureus / Q000302:isolation & purification
D004365:Drugs, Chinese Herbal