Test Method of Bacterial Endotoxin in Ceftazidime/Tazobactam Sodium for Injection / 中国药房

ABSTRACT

OBJECTIVE:To establish a method for testing the bacterial endotoxin in ceftazidime/tazobactam sodium for injection.METHODS:Based on the bacterial endotoxin test method stated in Chinese Pharmacopoeia(2005 edition),an interference test was conduced on different batches No.of ceftazidime/tazobactam sodium samples using actachypleus amebocyte lysate(TAL)from different companies.RESULTS:No interference was found in the bacterial endotoxin test after ceftazidime/tazobactam sodium for injection was diluted to 5.0 mg?mL-1.Its limit value of bacterial endotoxin was 0.1 EU?mL-1.CONCLUSION:Actachypleus amebocyte lysate test was suitable for determining bacterial endotoxin in ceftazidime/tazobactam sodium for injection.