摘要
目的建立生产系统中羟乙基淀粉200/0.5氯化钠注射液设备清洁验证的总有机碳(total organic carbon,TOC)分析方法。方法采用TOC分析仪检测清洁验证的样品,并建立了淋洗法与擦拭法结合的清洁操作规程。结果采用TOC法检测残留的羟乙基淀粉,具有良好的线性、回收率及精密度。结论 TOC法操作简便,灵敏度高,分析速度快,适用于羟乙基淀粉200/0.5氯化钠注射液设备的清洁验证。
Objective To establish an analysis method of total organic carbon（TOC） in equipment cleaning verification（CV） of Hydroxyethyl Starch 200/0.5 and Sodium Chloride Injection in production system. Methods The CV samples were analyzed with TOC analyzer, and the CV Standard Operating Procedure was established with the combination of rinse and swab wiping methods. Results TOC method for detecting hydroxyethyl starch residue showed good linearity, recovery and precision. Conclusion TOC method is simple, high sensitive, fast-speed, and can be used for equipment CV of Hydroxyethyl Starch 200/0.5 and Sodium Chloride Injection.
出处
《食品与药品》
CAS
2014年第6期438-440,共3页
Food and Drug
关键词
羟乙基淀粉200/0.5氯化钠注射液
清洁验证
总有机碳
淋洗水法
棉签擦拭法
Hydroxyethyl Starch 200/0.5 and Sodium Chloride Injection
cleaning verification
total organic carbon
rinse method
swab wiping method
