Methodology of Sterility Test of Dexrazoxane for Injection / 中国药房

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.