摘要
参照《中国药典》2005年版二部收载的细菌内毒素检查法中的凝胶法,建立了卡铂细菌内毒素检查方法。5.0mg/mL的卡铂及稀释液对细菌内毒素检查无干扰,对3个批号的供试品进行检查,结果均符合规定。结果表明,卡铂原料药采用细菌内毒素检查法是可行、有效的。
Referring to the testing methods which are recorded in 《 Chinese Pharmacopoeia 》 Vol. 2, 2005, a method for detection of bacterial endotoxin in carboplatin was established. The solution containing 5.0 mg/mL carboplatin and its dilute solutions do not interfere with the bacterial endotoxin test. The data of bacterial endotoxin test of three batches conform to the related requirements of carboplatin. The results showed that the bacterial endotoxin test is feasible and effective to detect bacterial endotoxin in carboplatin raw drug.
出处
《贵金属》
CAS
CSCD
北大核心
2009年第2期46-50,共5页
Precious Metals
基金
国家科技型中小企业技术创新项目(05C26215301434)
昆明市科技型中小企业技术创新基金项目(CJ2005016)
关键词
药物化学
卡铂原料药
细菌内毒素检查法
凝胶法
pharmic chemistry
carboplatin raw drug
bacterial endotoxin
gel -clot technique
