Methodology of Sterility Test of Dexrazoxane for Injection / 中国药房
China Pharmacy
;
(12)2007.
Artigo
em Chinês
| WPRIM
| ID: wpr-533230
ABSTRACT
OBJECTIVE:
To establish the method for sterility test of dexrazoxane for injection.METHODS:
The relative procedures were conducted in accordance with the membrane-filter procedure included in sterility test specified in Chinese Pharmacopoeia (2005 edition),with Staphylococcus aureus,Pseudomonas aeruginosa,Bacillus subtilis,Clostridium sporogenes,Candida albicans and Aspergillus niger as test organisms,which were flushed with sodium chloride-peptone buffer solution (150 mL,250 mL,and 350 mL,respectively,pH 7.0) to evaluate the impact of three flushing doses on the results of sterility test.RESULTS:
At a flushing dose of 150 mL,there was no growth of bacteria except Bacillus subtilis at 24~72 h;however,at a flushing dose of 250 mL or 350 mL,all bacteria strains had a good growth.CONCLUSION:
The established method for sterility test of dexrazoxane for injection is accurate and reliable.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Idioma:
Chinês
Revista:
China Pharmacy
Ano de publicação:
2007
Tipo de documento:
Artigo
Similares
MEDLINE
...
LILACS
LIS