Validation method for bacteria and fungi count in microbial limit test of drugs.
- Author:
Hua-Yu XU
1
;
Yun DU
;
Wen-Jing QIAN
;
Ying BAO
;
Fei LANG
;
Lin-Na YUAN
;
Wen LI
;
Yue-Qiu LIANG
;
Rui-Mian SHI
Author Information
- Publication Type:Journal Article
- MeSH: Aspergillus niger; isolation & purification; Bacillus subtilis; isolation & purification; Bacteria; isolation & purification; Candida albicans; isolation & purification; Colony Count, Microbial; methods; Drug Contamination; Drugs, Chinese Herbal; standards; Escherichia coli; isolation & purification; Fungi; isolation & purification; Staphylococcus aureus; isolation & purification
- From: China Journal of Chinese Materia Medica 2005;30(24):1918-1920
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVETo 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.
METHODAccording to the method set up for validation, the tested microorganisms with known counts were added to samples followed by the determination of the recovery.
RESULTWith different preparing method for testing samples, the recoveries for the tested microorganisms in testing samples were found to be over 70%.
CONCLUSIONValidation 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%.
